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 ISOFLEX OPTIM LEAD 1944/46 1944-46 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185716620]
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
[185716621]
It was reported that the atrial lead dislodged. After several attempts to reposition the lead and the patient being in chronic atrial fibrillation (af), the lead was explanted.
Patient Sequence No: 1, Text Type: D, B5
[187340228]
Analysis was normal. No anomalies were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938836-2020-02314 |
| MDR Report Key | 9899438 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2019-06-10 |
| 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-SUNNYVALE) |
| 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 | ISOFLEX OPTIM LEAD |
| Generic Name | PERMANENT PACEMAKER ELECTRODE |
| Product Code | NVY |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-17 |
| Model Number | 1944/46 |
| Catalog Number | 1944-46 |
| Lot Number | A000081223 |
| 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-SUNNYVALE) |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |