MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-29 for REOCOR S 365528 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[63612754]
Ous mdr - it was reported that the device stopped pacing without battery warning after an about 3 days of constant use. Even after the battery was exchanged, the control light blinked repeatedly, and a proper device function could no longer be established. The external pacemaker was exchanged, but the leads were left in place. The device was returned to biotronik for analysis.
Patient Sequence No: 1, Text Type: D, B5
[66229930]
The returned external pacemaker, including the redel adapter and the cable, was thoroughly analyzed. Aside from signs of wear, the analysis did not find any deviations that could be related to the complaint. The device underwent an extensive long-term test. Under additionally applied mechanical stress on reocor, adapter, and cable, no pacing interruption could be noted. The mechanical check found a mode setting dial that was hard to turn. Wear and tear during the more than 2 years of operating time was determined to be the cause. After repair, the device passed this test successfully. The electrical function check did not find any deviations at the cable pk-83 and at the redel adapter, and there was no indication of a device malfunction. The visual and mechanical analysis, as well as the function check, did not indicate a material defect or manufacturing error.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2016-05171 |
| MDR Report Key | 6214827 |
| Date Received | 2016-12-29 |
| Date of Report | 2016-12-15 |
| Date of Event | 2016-11-26 |
| Date Mfgr Received | 2017-01-17 |
| Device Manufacturer Date | 2014-06-06 |
| Date Added to Maude | 2016-12-29 |
| 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 | 2016-12-29 |
| Model Number | 365528 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-12-29 |