PULSE GENERATOR, PERMANENT, IMPLANTABLE
This device is manufactured by MDT PUERTO RICO OPERATIONS CO MED REL, MEDTRONIC, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO OPERATIONS CO, MEDTRONIC SA (SMO) and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 8 | Patient |
| 2024 | Vertigo | 1 | Patient |
| 2024 | Unspecified Infection | 98 | Patient |
| 2024 | Twiddlers Syndrome | 2 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Tachycardia | 9 | Patient |
| 2024 | Syncope/Fainting | 14 | Patient |
| 2024 | Swelling/ Edema | 15 | Patient |
| 2024 | Sleep Dysfunction | 1 | Patient |
| 2024 | Septic Shock | 3 | Patient |
| 2024 | Sepsis | 13 | Patient |
| 2024 | Rash | 2 | Patient |
| 2024 | Purulent Discharge | 13 | Patient |
| 2024 | Pulmonary Hypertension | 1 | Patient |
| 2024 | Presyncope | 2 | Patient |
| 2024 | Pocket Erosion | 9 | Patient |
| 2024 | Pericarditis | 1 | Patient |
| 2024 | Pericardial Effusion | 3 | Patient |
| 2024 | Paresthesia | 1 | Patient |
| 2024 | Pain | 18 | Patient |
| 2024 | Numbness | 1 | Patient |
| 2024 | Non specific EKG/ECG Changes | 1 | Patient |
| 2024 | Nausea | 3 | Patient |
| 2024 | Muscle Weakness/Atrophy | 5 | Patient |
| 2024 | Macular Edema | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Loss of consciousness | 1 | Patient |
| 2024 | Lethargy | 1 | Patient |
| 2024 | Itching Sensation | 3 | Patient |
| 2024 | Insufficient Information | 7 | Patient |
| 2024 | Inflammation | 1 | Patient |
| 2024 | Impaired Healing | 2 | Patient |
| 2024 | Hypoxia | 1 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2024 | High Blood Pressure/ Hypertension | 3 | Patient |
| 2024 | Hematoma | 2 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2024 | Heart Block | 3 | Patient |
| 2024 | Headache | 3 | Patient |
| 2024 | Fluid Discharge | 1 | Patient |
| 2024 | Fever | 7 | Patient |
| 2024 | Fatigue | 3 | Patient |
| 2024 | Fall | 3 | Patient |
| 2024 | Erythema | 25 | Patient |
| 2024 | Erosion | 15 | Patient |
| 2024 | Endocarditis | 4 | Patient |
| 2024 | Dyspnea | 13 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2024 | Dizziness | 17 | Patient |
| 2024 | Discomfort | 19 | Patient |
| 2024 | Diaphoresis | 2 | Patient |
| 2024 | Device Overstimulation of Tissue | 1 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Confusion/ Disorientation | 1 | Patient |
| 2024 | Chest Pain | 20 | Patient |
| 2024 | Cellulitis | 2 | Patient |
| 2024 | Cardiomyopathy | 2 | Patient |
| 2024 | Cardiac Tamponade | 2 | Patient |
| 2024 | Cardiac Arrest | 3 | Patient |
| 2024 | Bradycardia | 76 | Patient |
| 2024 | Blurred Vision | 1 | Patient |
| 2024 | Bacterial Infection | 10 | Patient |
| 2024 | Bacteremia | 12 | Patient |
| 2024 | Atrial Fibrillation | 4 | Patient |
| 2024 | Asystole | 5 | Patient |
| 2024 | Arrhythmia | 14 | Patient |
| 2024 | Appropriate Term / Code Not Available | 8 | Patient |
| 2024 | Anxiety | 1 | Patient |
| 2024 | Abscess | 1 | Patient |
| 2024 | Use of Device Problem | 1 | Device |
| 2024 | Under-Sensing | 1 | Device |
| 2024 | Signal Artifact/Noise | 2 | Device |
| 2024 | Reset Problem | 3 | Device |
| 2024 | Premature Discharge of Battery | 19 | Device |
| 2024 | Packaging Problem | 3 | Device |
| 2024 | Pacing Problem | 77 | Device |
| 2024 | Over-Sensing | 2 | Device |
| 2024 | Output Problem | 3 | Device |
| 2024 | Missing Test Results | 1 | Device |
| 2024 | Misconnection | 5 | Device |
| 2024 | Migration or Expulsion of Device | 11 | Device |
| 2024 | Mechanical Problem | 15 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Loose or Intermittent Connection | 1 | Device |
| 2024 | Insufficient Information | 4 | Device |
| 2024 | Inappropriate or Unexpected Reset | 1 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | False Alarm | 10 | Device |
| 2024 | Failure to Interrogate | 8 | Device |
| 2024 | Failure to Capture | 1 | Device |
| 2024 | Electromagnetic Interference | 4 | Device |
| 2024 | Electrical /Electronic Property Problem | 2 | Device |
| 2024 | Device Sensing Problem | 2 | Device |
| 2024 | Data Problem | 1 | Device |
| 2024 | Contamination | 1 | Device |
| 2024 | Communication or Transmission Problem | 2 | Device |
| 2024 | Circuit Failure | 3 | Device |
| 2024 | Battery Problem | 2 | Device |
| 2024 | Appropriate Term/Code Not Available | 46 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 108 | Device |
| 2023 | Wound Dehiscence | 6 | Patient |
| 2023 | Vertigo | 1 | Patient |
| 2023 | Unspecified Tissue Injury | 1 | Patient |
| 2023 | Unspecified Infection | 114 | Patient |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Twitching | 2 | Patient |
| 2023 | Twiddlers Syndrome | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Taste Disorder | 1 | Patient |
| 2023 | Tachycardia | 13 | Patient |
| 2023 | Syncope/Fainting | 26 | Patient |
| 2023 | Swelling/ Edema | 11 | Patient |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Sleep Dysfunction | 1 | Patient |
| 2023 | Shaking/Tremors | 1 | Patient |
| 2023 | Septic Shock | 1 | Patient |
| 2023 | Sepsis | 6 | Patient |
| 2023 | Rash | 1 | Patient |
| 2023 | Purulent Discharge | 13 | Patient |
| 2023 | Pulmonary Edema | 1 | Patient |
| 2023 | Presyncope | 3 | Patient |
| 2023 | Post Operative Wound Infection | 1 | Patient |
| 2023 | Pocket Erosion | 12 | Patient |
| 2023 | Pericardial Effusion | 1 | Patient |
| 2023 | Pain | 20 | Patient |
| 2023 | Non specific EKG/ECG Changes | 4 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Low Blood Pressure/ Hypotension | 4 | Patient |
| 2023 | Loss of consciousness | 3 | Patient |
| 2023 | Itching Sensation | 2 | Patient |
| 2023 | Ischemia Stroke | 1 | Patient |
| 2023 | Insufficient Information | 6 | Patient |
| 2023 | Impaired Healing | 2 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2023 | Hemothorax | 1 | Patient |
| 2023 | Hematoma | 4 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2023 | Heart Block | 1 | Patient |
| 2023 | Fluid Discharge | 2 | Patient |
| 2023 | Fever | 5 | Patient |
| 2023 | Fatigue | 3 | Patient |
| 2023 | Fall | 7 | Patient |
| 2023 | Erythema | 21 | Patient |
| 2023 | Erosion | 6 | Patient |
| 2023 | Endocarditis | 5 | Patient |
| 2023 | Dyspnea | 17 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 3 | Patient |
| 2023 | Dizziness | 15 | Patient |
| 2023 | Distress | 1 | Patient |
| 2023 | Discomfort | 16 | Patient |
| 2023 | Diaphoresis | 1 | Patient |
| 2023 | Device Overstimulation of Tissue | 3 | Patient |
| 2023 | Cramp(s) /Muscle Spasm(s) | 1 | Patient |
| 2023 | Cough | 1 | Patient |
| 2023 | Convulsion/Seizure | 1 | Patient |
| 2023 | Confusion/ Disorientation | 2 | Patient |
| 2023 | Chills | 2 | Patient |
| 2023 | Chest Pain | 8 | Patient |
| 2023 | Cellulitis | 3 | Patient |
| 2023 | Cardiomyopathy | 1 | Patient |
| 2023 | Cardiac Arrest | 3 | Patient |
| 2023 | Burning Sensation | 1 | Patient |
| 2023 | Bruise/Contusion | 1 | Patient |
| 2023 | Bradycardia | 44 | Patient |
| 2023 | Bacterial Infection | 17 | Patient |
| 2023 | Bacteremia | 5 | Patient |
| 2023 | Atrial Flutter | 2 | Patient |
| 2023 | Atrial Fibrillation | 5 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Arrhythmia | 8 | Patient |
| 2023 | Appropriate Term / Code Not Available | 16 | Patient |
| 2023 | Anxiety | 3 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Abdominal Pain | 1 | Patient |
| 2023 | Use of Device Problem | 4 | Device |
| 2023 | Unauthorized Access to Computer System | 2 | Device |
| 2023 | Unable to Obtain Readings | 5 | Device |
| 2023 | Signal Artifact/Noise | 3 | Device |
| 2023 | Reset Problem | 7 | Device |
| 2023 | Premature Discharge of Battery | 21 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Pacing Problem | 81 | Device |
| 2023 | Over-Sensing | 4 | Device |
| 2023 | Output above Specifications | 1 | Device |
| 2023 | Output Problem | 2 | Device |
| 2023 | Misconnection | 2 | Device |
| 2023 | Migration or Expulsion of Device | 8 | Device |
| 2023 | Mechanical Problem | 22 | Device |
| 2023 | Low impedance | 5 | Device |
| 2023 | Loose or Intermittent Connection | 2 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Incorrect Measurement | 1 | Device |
| 2023 | Inappropriate or Unexpected Reset | 4 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | False Alarm | 13 | Device |
| 2023 | Failure to Interrogate | 14 | Device |
| 2023 | Failure to Capture | 3 | Device |
| 2023 | Electromagnetic Interference | 5 | Device |
| 2023 | Electrical /Electronic Property Problem | 5 | Device |
| 2023 | Display or Visual Feedback Problem | 1 | Device |
| 2023 | Device-Device Incompatibility | 2 | Device |
| 2023 | Device Sensing Problem | 5 | Device |
| 2023 | Communication or Transmission Problem | 8 | Device |
| 2023 | Circuit Failure | 1 | Device |
| 2023 | Battery Problem | 4 | Device |
| 2023 | Appropriate Term/Code Not Available | 81 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 160 | Device |
| 2022 | Wound Dehiscence | 1 | Patient |
| 2022 | Unspecified Infection | 13 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Sepsis | 2 | Patient |
| 2022 | Presyncope | 1 | Patient |
| 2022 | Polymyositis | 1 | Patient |
| 2022 | Pocket Erosion | 2 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Osteomyelitis | 1 | Patient |
| 2022 | Numbness | 1 | Patient |
| 2022 | Non specific EKG/ECG Changes | 1 | Patient |
| 2022 | Nausea | 1 | Patient |
| 2022 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Insufficient Information | 5 | Patient |
| 2022 | Hematoma | 3 | Patient |
| 2022 | Heart Block | 1 | Patient |
| 2022 | Fatigue | 1 | Patient |
| 2022 | Failure of Implant | 1 | Patient |
| 2022 | Erythema | 1 | Patient |
| 2022 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2022 | Dizziness | 4 | Patient |
| 2022 | Chest Pain | 2 | Patient |
| 2022 | Cardiac Arrest | 4 | Patient |
| 2022 | Bradycardia | 3 | Patient |
| 2022 | Bacterial Infection | 3 | Patient |
| 2022 | Atrial Fibrillation | 1 | Patient |
| 2022 | Asystole | 1 | Patient |
| 2022 | Arrhythmia | 1 | Patient |
| 2022 | Appropriate Term / Code Not Available | 2 | Patient |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Unable to Obtain Readings | 2 | Device |
| 2022 | Signal Artifact/Noise | 4 | Device |
| 2022 | Reset Problem | 12 | Device |
| 2022 | Protective Measures Problem | 1 | Device |
| 2022 | Premature Discharge of Battery | 31 | Device |
| 2022 | Pacing Problem | 57 | Device |
| 2022 | Over-Sensing | 5 | Device |
| 2022 | Misconnection | 1 | Device |
| 2022 | Migration or Expulsion of Device | 6 | Device |
| 2022 | Mechanical Problem | 12 | Device |
| 2022 | Low impedance | 12 | Device |
| 2022 | Labelling, Instructions for Use or Training Problem | 1 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Incorrect Measurement | 1 | Device |
| 2022 | Inappropriate or Unexpected Reset | 7 | Device |
| 2022 | Impedance Problem | 1 | Device |
| 2022 | High impedance | 4 | Device |
| 2022 | High Capture Threshold | 2 | Device |
| 2022 | False Alarm | 19 | Device |
| 2022 | Failure to Interrogate | 9 | Device |
| 2022 | Electromagnetic Interference | 5 | Device |
| 2022 | Electrical /Electronic Property Problem | 2 | Device |
| 2022 | Device Sensing Problem | 2 | Device |
| 2022 | Device Dislodged or Dislocated | 1 | Device |
| 2022 | Decreased Sensitivity | 1 | Device |
| 2022 | Communication or Transmission Problem | 4 | Device |
| 2022 | Capturing Problem | 4 | Device |
| 2022 | Battery Problem | 3 | Device |
| 2022 | Appropriate Term/Code Not Available | 54 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 120 | Device |
| 2021 | Unspecified Infection | 7 | Patient |
| 2021 | Syncope/Fainting | 1 | Patient |
| 2021 | Stroke/CVA | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Muscle Weakness/Atrophy | 1 | Patient |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Bacterial Infection | 1 | Patient |
| 2021 | Bacteremia | 1 | Patient |
| 2021 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Reset Problem | 2 | Device |
| 2021 | Premature Discharge of Battery | 1 | Device |
| 2021 | Pacing Problem | 2 | Device |
| 2021 | Over-Sensing | 1 | Device |
| 2021 | Low impedance | 2 | Device |
| 2021 | Insufficient Information | 3 | Device |
| 2021 | Inappropriate or Unexpected Reset | 1 | Device |
| 2021 | False Alarm | 3 | Device |
| 2021 | Electromagnetic Interference | 1 | Device |
| 2021 | Display or Visual Feedback Problem | 2 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2020 | Pain | 1 | Patient |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Use of Device Problem | 1 | Device |
| 2020 | Product Quality Problem | 1 | Device |
| 2020 | Premature Discharge of Battery | 3 | Device |
| 2020 | Output Problem | 1 | Device |
| 2020 | Migration or Expulsion of Device | 1 | Device |
| 2020 | Battery Problem | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |