FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 4231260
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18081
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- September 11, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE HAD BEEN OBSERVED ON THE ATRIAL LEAD OF AN ASYMPTOMATIC PATIENT. THE LEAD WAS CAPPED DURING A DEVICE DOWNGRADE PROCEDURE. DAMAGE TO THE LEAD WAS NOTED AT THAT TIME BUT IT WAS THOUGHT TO HAVE OCCURRED DURING THE PROCEDURE. NO PATIENT SYMPTOMS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715885 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/46 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR |