MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-30 for ISOFLEX OPTIM LEAD 1948/52 1948-52 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185685446]
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
[185685447]
It was reported that the patient presented via remote transmission. Upon review, it was revealed that the right ventricular lead exhibited out of range, low pacing impedance. Also, the right ventricular lead exhibited a rise in capture threshold and decrease in sensing threshold. Programming changes were discussed. No interventions were made at this time. There were no consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04342 |
| MDR Report Key | 9897848 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-06 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2013-10-19 |
| 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 | ISOFLEX OPTIM LEAD |
| Generic Name | PERMANENT PACEMAKER ELECTRODE |
| Product Code | NVY |
| Date Received | 2020-03-30 |
| Model Number | 1948/52 |
| Catalog Number | 1948-52 |
| Lot Number | 4304892 |
| Device Expiration Date | 2016-10-31 |
| 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 | 2020-03-30 |