FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 4143142
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05647
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- January 17, 2012
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT WITH PAIN AT THE IMPLANT SITE PRESENTED IN CLINIC. THE DEVICE EXHIBITED NOISE. THE DEVICE REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31999 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, CRMD | 1888TC/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |