FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 4231351
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18157
- Event Type
- Injury
- 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
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND NORMAL LEAD CHARACTERISTICS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A SYNCOPAL EPISODE ON AN UNKNOWN DATE. THE RIGHT VENTRICULAR LEAD WAS PROGRAMMED WITH MAXIMUM OUTPUT SETTINGS AS A RESULT. ON (B)(6) 2014, X-RAY IMAGING REVEALED THAT A MICRO-DISLODGEMENT OF THE LEAD HAD OCCURRED. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Description of Event or Problem · 1
NEW INFORMATION NOTED THAT THE LEAD ALSO EXHIBITED HIGH CAPTURE THRESHOLDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715016 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1888TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Required Intervention | PM2210, 7443594, |