FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX LEAD
MDR report key: 4192323
·
Received January 11, 2014
Report
- Report Number
- 2017865-2014-02147
- Event Type
- Malfunction
- Date Received
- January 11, 2014
- Date of Event
- October 9, 2012
- Manufacturer
- ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
- Product Code
- DTB
- PMA / PMN Number
- P960030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFO PROVIDED BY MFR, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE FOLLOW UP, MULTIPLE HIGH VENTRICULAR RATE EPISODES ON THE DEVICE AND NOISE REVERSIONS ON THE LEAD WERE SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22388 | ISOFLEX LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | 1944/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2443519| 2212 |