FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX LEAD
MDR report key: 1896237
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05190
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 13, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. FAILURE (EVENT) OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND SILICONE MEDICAL ADHESIVE ON THE RING ELECTRODE.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOFLEX LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1944/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |