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.
[123578456]
We received a voluntary medwatch report from the fda. The report was sent in from (b)(6) health ((b)(4)). The report is: when a (b)(6) year old male was at a critical time in the surgery the external pacemaker and cable failed to properly function. The patient's heart quickly distended and a hole was emergently made in the heart to decompress the heart in order to save the patient. Once a proper functioning cable and box were retrieved (2 boxes later), the hole that was emergently made needed to be fixed. (b)(6) health cannot provide the serial numbers of the external pacemakers that were used. (b)(6) health claimed that the devices were sent to their biomed group where they tested fine and were not returned to biotronik.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2018-03492 |
| MDR Report Key | 7962354 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-12 |
| Date of Report | 2018-09-25 |
| Date Mfgr Received | 2018-09-25 |
| 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 |