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 2020-03-31 for DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR 7122Q/65 7122Q-65 manufactured by Abbott.
[185934762]
This product is registered as a combination product. The results, method, and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[185934763]
During implant, it was reported that r wave amplitude variation was observed on the right ventricular (rv) lead. The helix of the rv lead failed to insert after attempted implant. A different rv lead was used and was successfully implanted. The patient was stable following the procedure and there were no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2020-02371 |
| MDR Report Key | 9908368 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-17 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-10-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELIZABETH BOLTZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer G1 | ABBOTT |
| Manufacturer Street | 645 ALMANOR AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR |
| Generic Name | DEFIBRILLATION LEAD |
| Product Code | NVY |
| Date Received | 2020-03-31 |
| Model Number | 7122Q/65 |
| Catalog Number | 7122Q-65 |
| Lot Number | A000088192 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |