FDA Adverse Event
Injury
Summary report: N
TENDRIL ST
MDR report key: 3924106
·
Received July 9, 2014
Report
- Report Number
- 2017865-2014-15038
- Event Type
- Injury
- Date Received
- July 9, 2014
- Date of Event
- May 23, 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
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: FINAL ANALYSIS FOUND THE LEAD EXHIBITED CLAVICULAR CRUSH DAMAGE AT 26.4 CM TO 26.9 CM FROM THE CONNECTOR PIN. THE OUTER INSULATION WAS DAMAGED AT THIS SAME LOCATION WHICH EXPOSED THE OUTER COIL. THIS DAMAGE LIKELY CONTRIBUTED TO THE REPORTED ANOMALIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM EXPERIENCING CHEST PAIN. THE ATRIAL LEAD EXHIBITED NOISE AND AN IMPEDANCE MEASUREMENT ANOMALY. THE LEAD WAS EXPLANTED AND REPLACED ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 399798 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 1882TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | 1948/58, CPD155306 |