MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-10-12 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[123577318]
We received a voluntary medwatch report from the fda. The report was sent in from (b)(6) health ((b)(4)). The report is: when an (b)(6) year old male was being taken off the bypass machine and the team was trying to get his heart started again, pacing wires were inserted into the heart and connected to the pacing cables and to the external pacemaker. The pacing didn't work with the first set of cables and external pacemaker. The cables were changed out with still no change. The external pacemaker was changed out with still no pacing. Everything was changed out 3 times with no success. Finally the physician used a competitor's device and cables and pacing was achieved. The hospital could not provide any serial numbers in this complaint. They also said that the devices were returned to their biomed department and all devices checked out fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2018-03493 |
| MDR Report Key | 7962318 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2018-10-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-10-12 |
| Model Number | 365529 |
| 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. Hospitalization | 2018-10-12 |