MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-20 for ITREVIA 5 DR-T DF4 PROMRI 392421 SEE MODEL NO. manufactured by Biotronik Se & Co. Kg.
[184372863]
After an implantation period of approx. 32 months, oversensing with inappropriate therapies was reported. The patient was hospitalized. Apart from the shocks, no further adverse patient side effects have been reported. The lead was capped and the device was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1028232-2020-01372 |
| MDR Report Key | 9862716 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2017-03-17 |
| Date Added to Maude | 2020-03-20 |
| 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 | ITREVIA 5 DR-T DF4 PROMRI |
| Generic Name | ICD |
| Product Code | MRM |
| Date Received | 2020-03-20 |
| Model Number | 392421 |
| Catalog Number | SEE MODEL NO. |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOTRONIK SE & CO. KG |
| Manufacturer Address | WOERMANNKEHRE 1 BERLIN 12359 DE 12359 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-20 |