MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-01-15 for ISOFLEX OPTIM LEAD 1948/58 SMTFY999 manufactured by St. Jude Medical, Inc. Crmd.
[4864212]
It was reported that the lead exhibited out of range high impedance during implant. The lead was not used.
Patient Sequence No: 1, Text Type: D, B5
[12222580]
All information provided by manufacturer, no medwatch form was received. This historical complaint is being filed as part of a retrospective review of complaint files in response to a recent fda inspection. There is no change to the actual performance of the product and this report only represents an enhancement to the reporting criteria going forward. Analysis was normal. No anomaly was found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2014-09135 |
| MDR Report Key | 4054577 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-01-15 |
| Date of Event | 2011-06-06 |
| Date Facility Aware | 2011-06-06 |
| Date Mfgr Received | 2011-06-06 |
| Device Manufacturer Date | 2011-04-01 |
| Date Added to Maude | 2014-09-08 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CARY LAWLER |
| Manufacturer Street | 15900 VALLEY VIEW CT. |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer Phone | 8184932621 |
| Manufacturer G1 | ST. JUDE MEDICLA, INC. |
| Manufacturer Street | 15900 VALLEY VIEW CT. |
| 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, DTS |
| Product Code | DTS |
| Date Received | 2014-01-15 |
| Returned To Mfg | 2011-07-04 |
| Model Number | 1948/58 |
| Catalog Number | SMTFY999 |
| Device Expiration Date | 2014-04-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. CRMD |
| Manufacturer Address | 15900 VALLEY VIEW CT. SYLMAR CA 91342913 US 91342 9134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-15 |