MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-12 for TELIGEN E110 manufactured by Boston Scientific.
[89347279]
Pt came into clinic due to beeping icd device on (b)(6) 2014. Upon interrogation, error code 1003 was present stating "battery voltage is too low for projected remaining capacity. " boston scientific technical services were contacted and said device would need to be changed out within seven days. They further explained the error code by saying there were "power fluctuations that were intermittent, not steady" as part of the cause. Previous icd check was on (b)(6) 2013 and battery at 7. 5 years remaining at that time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072718 |
| MDR Report Key | 6943804 |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-10 |
| Date of Event | 2014-06-19 |
| Date Added to Maude | 2017-10-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TELIGEN E110 |
| Generic Name | INTERNAL CARDIAC DEFIBRILLATOR |
| Product Code | NHW |
| Date Received | 2017-10-12 |
| Model Number | E110 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2017-10-12 |