FDA Adverse Event
Injury
Summary report: N
ISOFLEX OPTIM LEAD
MDR report key: 3923505
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14775
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- May 9, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DTB
- PMA / PMN Number
- P960030
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
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 ONE DAY POST-IMPLANT, THE ATRIAL LEAD DISLODGED. THE LEAD WAS REPOSITIONED. ON (B)(6) 2014, THE PATIENT WAS PRESENTED FOR ROUTINE POST-OPERATIVE FOLLOW UP. A CHEST X-RAY REVEALED THE LEAD HAD DISLODGED AGAIN. THE DEVICE WAS PROGRAMMED TO A SINGLE CHAMBER MODE VVTR AND THE LEAD REMAINED IN SITU. THE PATIENT WAS IN GOOD CONDITION.
Description of Event or Problem · 1
NEW INFORMATION NOTES: IT WAS REPORTED THAT THE LEAD WAS SUCCESSFULLY REPOSITIONED. THE PATIENT WAS IN GOOD CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399571 | ISOFLEX OPTIM LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC., CRMD | 1944/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Required Intervention |