MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for TELIGEN E102 manufactured by Boston Scientific Corporation.
[185768053]
The returned implantable cardioverter defibrillator (icd) device was analyzed and a review of the device memory confirmed that a low voltage alert, code 1003, was recorded. The battery voltage was lower than expected, but still supported full device function. Using historical daily battery voltage measurement data, engineers determined that this device was demonstrating behavior consistent with a high current condition associated with a compromised low voltage capacitor connected to the device's battery. Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times. Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal. Boston scientific has issued an advisory communication regarding an older subset of cognis/teligen devices that is more susceptible to this anomaly. Specifically, the performance of a low voltage capacitor may be compromised over time, causing an increased current drain that can lead to premature battery depletion. This particular device was included in the advisory population.
Patient Sequence No: 1, Text Type: N, H10
[185768094]
It was reported that this implantable cardioverter defibrillator (icd) device was explanted and replaced due to normal battery depletion. There were no reported field allegations made against the device performance. In addition, there were no reported adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-06542 |
| MDR Report Key | 9904970 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-11-19 |
| Date Mfgr Received | 2019-12-19 |
| Device Manufacturer Date | 2009-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0087-2015 Z-0088-2015 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TELIGEN |
| Generic Name | IMPLANTABLE DEVICE |
| Product Code | LWP |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2019-11-19 |
| Model Number | E102 |
| Catalog Number | E102 |
| Lot Number | 241293 |
| Device Expiration Date | 2010-03-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |