MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-20 for REOCOR D 365529 manufactured by Biotronik Se & Co. Kg.
[2755941]
Ous mdr - the pt inadvertently unlocked and detached the cable from this external pacemaker, resulting in a non-pacing situation. The immediate reaction of the present cardiologist prevented the adverse threat to the pacemaker dependent pt.
Patient Sequence No: 1, Text Type: D, B5
[10030953]
Ous mdr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2012-02089 |
| MDR Report Key | 2709515 |
| Report Source | 01,07 |
| Date Received | 2012-08-20 |
| Date of Report | 2012-08-10 |
| Date of Event | 2012-06-30 |
| Date Mfgr Received | 2012-08-10 |
| Date Added to Maude | 2012-08-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 6024 JEAN ROAD |
| Manufacturer City | LAKE OSWEGO OR 97035 |
| Manufacturer Country | US |
| Manufacturer Postal | 97035 |
| Manufacturer Phone | 8772459800 |
| Manufacturer G1 | BIOTRONIK SE & CO. KG |
| Manufacturer City | BERLIN |
| Manufacturer Country | GM |
| 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 | 2012-08-20 |
| Model Number | 365529 |
| Catalog Number | 365529 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | BERLIN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-20 |