FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 3903449
·
Received June 30, 2014
Report
- Report Number
- 2017865-2014-13978
- Event Type
- Injury
- Date Received
- June 30, 2014
- Date of Event
- March 5, 2014
- 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED HIGH IMPEDANCE AND A LEAD FRACTURE WAS SUSPECTED. ON (B)(6) 2014 THE LEAD ALSO EXHIBITED NOISE AND HAD DISLODGED WHICH LED TO IT BEING EXPLANTED AND REPLACED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION THAT ON (B)(6) 2014 THE ATRIAL LEAD HAD EXHIBITED LOSS OF SENSING. AN X-RAY REVEALED THAT THE LEAD HAD DISLODGED AND WAS SCHEDULED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 379288 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 38 YR | Required Intervention |