PULSE GENERATOR, PERMANENT, IMPLANTABLE
This device is manufactured by MDT PUERTO RICO OPERATIONS CO MED REL, MDT SOFAMOR DANEK PUERTO RICO MFG, MEDTRONIC, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 6 | Patient |
| 2024 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Purulent Discharge | 1 | Patient |
| 2024 | Presyncope | 1 | Patient |
| 2024 | Pocket Erosion | 2 | Patient |
| 2024 | Paresthesia | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hypoxia | 1 | Patient |
| 2024 | Heart Block | 2 | Patient |
| 2024 | Fever | 3 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Erythema | 1 | Patient |
| 2024 | Endocarditis | 1 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2024 | Dizziness | 2 | Patient |
| 2024 | Discomfort | 2 | Patient |
| 2024 | Diaphoresis | 1 | Patient |
| 2024 | Cyst(s) | 1 | Patient |
| 2024 | Chest Pain | 2 | Patient |
| 2024 | Cardiomyopathy | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Bradycardia | 10 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Bacteremia | 3 | Patient |
| 2024 | Arrhythmia | 3 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Altered State of Consciousness | 1 | Patient |
| 2024 | Signal Artifact/Noise | 1 | Device |
| 2024 | Reset Problem | 2 | Device |
| 2024 | Premature Discharge of Battery | 6 | Device |
| 2024 | Pacing Problem | 15 | Device |
| 2024 | Output Problem | 1 | Device |
| 2024 | Migration or Expulsion of Device | 1 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | High impedance | 1 | Device |
| 2024 | Failure to Interrogate | 10 | Device |
| 2024 | Failure to Capture | 2 | Device |
| 2024 | Electromagnetic Interference | 1 | Device |
| 2024 | Battery Problem | 3 | Device |
| 2024 | Appropriate Term/Code Not Available | 8 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2023 | Unspecified Infection | 7 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Tachycardia | 2 | Patient |
| 2023 | Syncope/Fainting | 6 | Patient |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Septic Shock | 1 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Presyncope | 1 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Myocardial Infarction | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Loss of consciousness | 1 | Patient |
| 2023 | Irritability | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Heart Block | 1 | Patient |
| 2023 | Head Injury | 1 | Patient |
| 2023 | Fatigue | 4 | Patient |
| 2023 | Fall | 1 | Patient |
| 2023 | Endocarditis | 1 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2023 | Dizziness | 5 | Patient |
| 2023 | Diaphoresis | 1 | Patient |
| 2023 | Device Overstimulation of Tissue | 1 | Patient |
| 2023 | Cardiogenic Shock | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Calcium Deposits/Calcification | 1 | Patient |
| 2023 | Bradycardia | 18 | Patient |
| 2023 | Bacterial Infection | 2 | Patient |
| 2023 | Atrial Fibrillation | 1 | Patient |
| 2023 | Asystole | 2 | Patient |
| 2023 | Arrhythmia | 3 | Patient |
| 2023 | Appropriate Term / Code Not Available | 4 | Patient |
| 2023 | Unauthorized Access to Computer System | 1 | Device |
| 2023 | Unable to Obtain Readings | 1 | Device |
| 2023 | Signal Artifact/Noise | 3 | Device |
| 2023 | Reset Problem | 2 | Device |
| 2023 | Premature Discharge of Battery | 11 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Pacing Problem | 17 | Device |
| 2023 | Over-Sensing | 2 | Device |
| 2023 | Output above Specifications | 1 | Device |
| 2023 | Output Problem | 2 | Device |
| 2023 | Mechanical Problem | 2 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | High Capture Threshold | 1 | Device |
| 2023 | False Positive Result | 2 | Device |
| 2023 | Failure to Interrogate | 12 | Device |
| 2023 | Failure to Capture | 2 | Device |
| 2023 | Electromagnetic Interference | 1 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Communication or Transmission Problem | 12 | Device |
| 2023 | Battery Problem | 5 | Device |
| 2023 | Appropriate Term/Code Not Available | 16 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 16 | Device |
| 2022 | Unspecified Infection | 3 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Sleep Dysfunction | 1 | Patient |
| 2022 | Muscle Weakness/Atrophy | 1 | Patient |
| 2022 | Hematoma | 1 | Patient |
| 2022 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2022 | Fatigue | 1 | Patient |
| 2022 | Erosion | 1 | Patient |
| 2022 | Dizziness | 3 | Patient |
| 2022 | Chest Pain | 2 | Patient |
| 2022 | Cardiomyopathy | 1 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Bacterial Infection | 1 | Patient |
| 2022 | Arteriosclerosis/ Atherosclerosis | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unable to Obtain Readings | 3 | Device |
| 2022 | Signal Artifact/Noise | 1 | Device |
| 2022 | Premature Discharge of Battery | 14 | Device |
| 2022 | Pacing Problem | 18 | Device |
| 2022 | Over-Sensing | 3 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | Intermittent Capture | 1 | Device |
| 2022 | Insufficient Information | 5 | Device |
| 2022 | Impedance Problem | 1 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | False Positive Result | 1 | Device |
| 2022 | Failure to Interrogate | 9 | Device |
| 2022 | Failure to Capture | 5 | Device |
| 2022 | Electromagnetic Interference | 1 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Communication or Transmission Problem | 3 | Device |
| 2022 | Capturing Problem | 1 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 17 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2021 | Unspecified Infection | 1 | Patient |
| 2021 | Septic Shock | 1 | Patient |
| 2021 | Discomfort | 1 | Patient |
| 2021 | Bacterial Infection | 1 | Patient |
| 2021 | Anxiety | 1 | Patient |
| 2021 | Premature Discharge of Battery | 2 | Device |
| 2021 | Missing Test Results | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | False Positive Result | 1 | Device |
| 2021 | Battery Problem | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Unspecified Infection | 1 | Patient |
| 2020 | Tachycardia | 1 | Patient |
| 2020 | Pacing Problem | 1 | Device |
| 2020 | Capturing Problem | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 2 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |