FDA Adverse Event
Injury
Summary report: N
ISOFLEX LEAD
MDR report key: 4191789
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04658
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- May 12, 2011
- Manufacturer
- ST. JUDE MEDICAL INC. CRMD
- Product Code
- DTB
- PMA / PMN Number
- P960030
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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. FINAL ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND. (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED A SENSING ANOMALY. THE LEAD WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 29568 | ISOFLEX LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL INC. CRMD | 1944/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |