FDA Adverse Event
Malfunction
Summary report: N
TENDRIL STS
MDR report key: 5775490
·
Received July 7, 2016
Report
- Report Number
- 2017865-2016-04569
- Event Type
- Malfunction
- Date Received
- July 7, 2016
- Date of Event
- May 13, 2016
- Report Date
- May 23, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT THE PHYSICIAN ASKED NURSE FOR A LEAD, THE BOX WAS LABELED MODEL AS 2088TC/52 CM WITH SERIAL NUMBER AS (B)(4), HOWEVER THE LABEL ON THE LEAD STATES MODEL AS 2088TC/58 CM WITH SERIAL NUMBER CAW*****. NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 430591 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC/52 | A000017838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |