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 2017-08-15 for REOCOR S 365528 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[82762420]
Ous mdr - it was reported that an alert was notet by central monitor at the hospital. When a staff arrived at the patient room, flashing led of both sensing and pacing of the reocor was observed. As it was assumed that pacing might have interrupted, the reocor was exchanged immediately. Since the patient had self-pulse (30 bpm) , the event did not cause any adverse events.
Patient Sequence No: 1, Text Type: D, B5
[106978319]
Upon receipt, the external pacemaker was inspected. No deviation was found related to the clinical observation during analysis. No indication which might have contributed to the clinical observation was revealed. 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 | 1028232-2017-02813 |
| MDR Report Key | 6796354 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-15 |
| Date of Report | 2017-08-03 |
| Date of Event | 2017-06-24 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2014-12-12 |
| Date Added to Maude | 2017-08-15 |
| 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 | 2017-08-15 |
| 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 | 1. Required No Informationntervention | 2017-08-15 |