FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 4193315
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-04389
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- February 22, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- DTB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, 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. EVALUATION DESCRIPTION: THE REPORTED FIELD COMPLAINT OF HIGH IMPEDANCE WAS NOT CONFIRMED IN THE LABORATORY. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NO ANOMALY WAS FOUND, (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT THE LEAD IMPEDANCE INCREASED AND WOULD NOT LOWER DESPITE CHANGING POSITIONS. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30393 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, INC., CRMD | 2088TC/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |