FDA Adverse Event
Injury
Summary report: N
ISOFLEX OPTIM LEAD
MDR report key: 1411237
·
Received July 9, 2009
Report
- Report Number
- 2017865-2009-01935
- Event Type
- Injury
- Date Received
- July 9, 2009
- Date of Event
- April 20, 2009
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IN 2009, THE PATIENT PRESENTED TO THE HOSPITAL FOR EXTER- NAL SUTURE REMOVAL. PACING THRESHOLD HAD RISEN FROM 0.5 V AT 0.5 MS AT IMPLANT TO 3.75 V AT 1 MS. THE LEAD WAS IN THE CORRECT POSITION AS VIEWED UNDER FLUOROSCOPY. AT ABOUT 3 DAYS LATER, THRESHOLD HAD RISEN TO 6 V AT 1 MS. THE PHYSICIAN DECIDED TO REPOSITION THE LEAD. DURING THE PROCEDURE, INSULATION DAMAGE WAS FOUND. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT NO SUTURE SLEEVE WAS USED AT IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX OPTIM LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1948/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 | Required Intervention |