FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX
MDR report key: 3925817
·
Received July 10, 2014
Report
- Report Number
- 2017865-2014-15658
- Event Type
- Injury
- Date Received
- July 10, 2014
- Date of Event
- November 1, 2013
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. FINAL ANALYSIS FOUND INSULATION ABRASION IN SUTURE SLEEVE TIE DOWN REGION AT 20.7 CM FROM THE CONNECTOR PIN; WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT DETECTED IN THE FIELD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED LOW IMPEDANCE IN (B)(6) 2013. NOISE WAS NOTED ON THE LEAD AT SUBSEQUENT FOLLOW-UPS. THE NOISE WAS REPRODUCIBLE WITH ISOMETRICS. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 404554 | TENDRIL SDX | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1688TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |