FDA Adverse Event
Injury
Summary report: N
QUARTET
MDR report key: 4191768
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04684
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- December 19, 2012
- Manufacturer
- ST. JUDE MEDICAL INC. CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
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. ANALYSIS WAS NORMAL. NO ANOMALY FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD DISLODGED, COULD NOT BE REPOSITIONED DURING UPGRADE OF PULSE GENERATOR. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28892 | QUARTET | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL INC. CRMD | 1458Q/86 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Required Intervention |