MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for REOCOR S 365528 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[57720386]
Ous mdr - it was reported that the pulse rate output of the device was too high in comparison to the programmed rate. The device was returned to biotronik. No deterioration of the patient's state of health was reported. The event date was not provided.
Patient Sequence No: 1, Text Type: D, B5
[63285058]
Please note "usage of device" should be reuse. The returned external pacemaker was thoroughly analyzed. It was principally capable to pace and sense. However, it was found during the analysis that the external damages to the operating elements did not allow for a proper operation. Damage and soiling was found. The housing is cracked several times and fractured, and all setting wheels are hard to turn because of the dirt. The visual and mechanical analysis, as well as the function check, did not show any indications of a material defect or manufacturing error. The device was damaged by external impacts.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2016-03744 |
| MDR Report Key | 6036469 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-19 |
| Date Mfgr Received | 2016-11-24 |
| Device Manufacturer Date | 2012-01-04 |
| Date Added to Maude | 2016-10-18 |
| 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 | 2016-10-18 |
| 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. Other | 2016-10-18 |