FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX OPTIM LEAD
MDR report key: 3924096
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-15025
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- April 14, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DTB
- PMA / PMN Number
- P960030
- Removal / Correction Number
- NA
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS INSERTED INTO THE DEVICE HEADER WITH DIFFICULTY. AT THE END OF THE IMPLANT ALL THE ELECTRICAL MEASUREMENTS WERE NORMAL. THE LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400205 | ISOFLEX OPTIM LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC., CRMD | 1944/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |