MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-12-04 for REOCOR D 365529 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[4148517]
Ous mdr - it was reported that pacing loss occurred and the patient had to be resuscitated. Manual cpr had to be administered to the patient until a replacement device was connected.
Patient Sequence No: 1, Text Type: D, B5
[11673035]
(b)(4). The device was visually inspected for external damage, and the mechanical operability was tested. The device showed damage on and inside the housing. The damaged parts were replaced after the function check. The damages noted on the device suggest a fall. A function check was performed in another part of the analysis. It was divided into the following analytic steps: activation of the device, check of the display elements, measurement of pacing/sensing. The device was turned on, the self-test was successful, and the device was ready to operate. Pacing was tested in another step. An intermittent pacing function was detected. The device was then opened. The cause for the intermittent pacing function was connection plug for the ventricular channel that had become loose. Both the damaged housing parts and the entire main board with the connection plugs were replaced. A final factory test was performed at the end. The device has passed this test. In summary, the device showed external and internal damage. This damage was the cause for the clinical observation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1028232-2013-03541 |
| MDR Report Key | 3499190 |
| Report Source | 01,07 |
| Date Received | 2013-12-04 |
| Date of Report | 2013-11-19 |
| Date Mfgr Received | 2014-02-06 |
| Device Manufacturer Date | 2011-03-30 |
| Date Added to Maude | 2014-01-27 |
| 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 |
| 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 | 2013-12-04 |
| Model Number | 365529 |
| 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. Hospitalization | 2013-12-04 |