MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for TELIGEN F103 manufactured by Boston Scientific Corporation.
[185919258]
It is indicated that the device was disposed at the facility and will not be returned for evaluation; therefore, a technical analysis cannot be conducted. Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident. As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
[185919259]
It was reported that this implantable device recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity. Subsequently, the device was explanted and replaced. There were no patient complications or adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-06036 |
| MDR Report Key | 9900907 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Device Manufacturer Date | 2012-01-31 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TELIGEN |
| Generic Name | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
| Product Code | LWP |
| Date Received | 2020-03-30 |
| Model Number | F103 |
| Catalog Number | F103 |
| Lot Number | 117009 |
| Device Expiration Date | 2013-01-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-30 |