MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for ELUNA 8 DR-T PROMRI 394969 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[185945316]
System was explanted due to infection. There is currently no indication that a new system has been implanted. Should additional information be received, this file will be updated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-01497 |
| MDR Report Key | 9905532 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-30 |
| Date Mfgr Received | 2020-04-01 |
| Device Manufacturer Date | 2016-05-17 |
| Date Added to Maude | 2020-03-31 |
| 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 | ELUNA 8 DR-T PROMRI |
| Generic Name | PACEMAKER |
| Product Code | NVZ |
| Date Received | 2020-03-31 |
| Model Number | 394969 |
| Catalog Number | SEE MODEL NO. |
| Device Expiration Date | 2017-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN 12359 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-31 |