FDA Adverse Event
Malfunction
Summary report: N
TENDRIL ST
MDR report key: 3923980
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-14911
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Date of Event
- April 8, 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
- MX
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT, THE VENTRICULAR LEAD EXHIBITED INTERMITTENT CAPTURE AND LOW IMPEDANCE. THE LEAD WAS NOT USED AND A NEW LEAD WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400866 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |