FDA Adverse Event
Malfunction
Summary report: N
TENDRIL SDX
MDR report key: 17535748
·
Received August 12, 2023
Report
- Report Number
- MW5142642
- Event Type
- Malfunction
- Date Received
- August 12, 2023
- Report Date
- September 1, 2011
- Manufacturer
- ST. JUDE MEDICAL
- Product Code
- NVZ
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
TECHNICAL SERVICES RECEIVED A CALL ON 08/19/2011 FROM SALES REP. IT WAS REPORTED THAT THE LEAD HAD HIGH IMPEDANCE. NO PHYSICIAN OR HOSPITAL KNOWN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 940466 | TENDRIL SDX | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | ST. JUDE MEDICAL | 1488TC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |