MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-02 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[44174595]
Technician claims that external pacemaker stopped pacing when cover was slid down. They would like an analysis on why this happened or to verify that the unit is working normally. Patient was dependent on unit and another was swapped in.
Patient Sequence No: 1, Text Type: D, B5
[55736431]
Upon receipt, the external pacemaker including the redel adapter was inspected. Apart from signs of usage no deviation was found related to the clinical observation during analysis. Further analysis including an intensive long term investigation of the device pacing and sensing functions under mechanical stress did not reveal any indication of a device malfunction. In particular the use of the protective cover and its possible effects on the stimulation behavior was observed, but no anomaly could be found. In summary, the visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2016-01440 |
| MDR Report Key | 5624356 |
| Date Received | 2016-05-02 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-04-04 |
| Date Mfgr Received | 2016-09-22 |
| Device Manufacturer Date | 2012-10-11 |
| Date Added to Maude | 2016-05-02 |
| 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 D |
| Generic Name | EXTERNAL PACEMAKER |
| Product Code | OVJ |
| Date Received | 2016-05-02 |
| Model Number | 365529 |
| 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 | 1. Life Threatening | 2016-05-02 |