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 2017-01-03 for REOCOR S 365528 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[63798880]
It was reported that the external pacemaker did not turn on and did not stimulate. The external pacemaker was returned to biotronik for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2016-05187 |
| MDR Report Key | 6220603 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-03 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-07-11 |
| Date Mfgr Received | 2018-12-27 |
| Device Manufacturer Date | 2016-01-14 |
| Date Added to Maude | 2017-01-03 |
| 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 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 | REOCOR S |
| Generic Name | EXTERNAL PACEMAKER |
| Product Code | OVJ |
| Date Received | 2017-01-03 |
| Model Number | 365528 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN D-12359 GM D-12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-03 |