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 SENTUS PROMRI OTW QP S-85/49 406082 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[185784966]
Loss of capture was observed and lead was found to be dislodged. Lead was explanted and replaced. No adverse patient events were reported. Should additional information become available, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-01496 |
| MDR Report Key | 9905515 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2017-09-25 |
| 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 Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENTUS PROMRI OTW QP S-85/49 |
| Generic Name | LV LEAD |
| Product Code | OJX |
| Date Received | 2020-03-31 |
| Model Number | 406082 |
| Catalog Number | SEE MODEL NO. |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN 12359 DE 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-31 |