MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR 7122Q/65 7122Q-65 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185710095]
The results/method and conclusion codes along with investigation results will be provided in the final report. This product is registered as a combination product.
Patient Sequence No: 1, Text Type: N, H10
[185710096]
It was reported that the patient presented for revision of the right ventricular lead due to increased capture threshold, and decreased sensing values. Unstable impedance measurements were also noted. The lead was explanted and replaced. The patient was in stable condition.
Patient Sequence No: 1, Text Type: D, B5
[188596832]
The reported events of high capture, under-sensing, and inadequate impedance were not confirmed. As received, a complete lead with a clip-on tool was returned in one piece for analysis. Electrical testing did not find any indication of conductor fractures or internal shorts. X-ray and visual inspection of the lead found no anomalies.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2020-04407 |
| MDR Report Key | 9900990 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2018-08-31 |
| Date Added to Maude | 2020-03-30 |
| 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 | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| 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 | 2020-03-30 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 7122Q/65 |
| Catalog Number | 7122Q-65 |
| Lot Number | A000083469 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |