FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX LEAD
MDR report key: 4192058
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04664
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC. CRMD
- Product Code
- DTB
- PMA / PMN Number
- P960030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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. THE REPORTED FIELD EVENT OF UNABLE TO INSERT STYLET WAS CONFIRMED IN THE LABORATORY. ANALYSIS FOUND THAT THE INNER COIL WAS OFFSET. THE CAUSE OF THE OFFSET COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STYLET COULD NOT BE INSERTED INTO THE LEAD FULLY. THE LEAD WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27882 | ISOFLEX LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC. CRMD | 1944/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |