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 2020-03-31 for DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR 7120Q/58 7120Q-58 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185931044]
This product is registered as a combination product. Further information was requested but was not available. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[185931045]
It was reported that noise resulting in non sustained right ventricular oversensing, aborted shocks and low pacing impedance was observed on the right ventricular lead. The patient felt a jolt but it didn't appear to have been from a shock. Th patient was pending further.
Patient Sequence No: 1, Text Type: D, B5
[186731556]
Further information was requested but was not yet received.
Patient Sequence No: 1, Text Type: N, H10
[186731557]
New information received notes further testing revealed noise with isometric testing. The patient subsequently received one inappropriate shock. Right ventricular capture thresholds were increased and r waves were diminished. The patient was brought in for a procedure for downgrade due to the noise. The right ventricular lead was capped (b)(6) 2020 and replaced.
Patient Sequence No: 1, Text Type: D, B5
[188600027]
Should include the patient was stable following the procedure.
Patient Sequence No: 1, Text Type: N, H10
[188600028]
The patient's status was noted as stable following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04469 |
| MDR Report Key | 9908244 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2010-09-28 |
| 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 | 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 | 2020-03-31 |
| Model Number | 7120Q/58 |
| Catalog Number | 7120Q-58 |
| Lot Number | 3220781 |
| Device Expiration Date | 2011-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-31 |