MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-02 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[137659207]
Patient was hooked up to this device post cabg procedure. Pt came off bypass pacing and started fibrillating. The patient was shocked twice and had to go back on bypass, but started fibrillating again. Patient was shocked again. External pacemakers were exchanged and the patient was able to come off bypass. The nurse believed that the external pacemaker was pacing the patient too fast. Should additional information be received, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2019-00826 |
| MDR Report Key | 8384726 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-02 |
| Date of Report | 2018-10-09 |
| Date of Event | 2018-10-09 |
| Date Mfgr Received | 2019-06-25 |
| Date Added to Maude | 2019-03-02 |
| 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 |
| 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 | 2019-03-02 |
| Model Number | 365529 |
| Catalog Number | SEE MODEL NO. |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-03-02 |