FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 15937457
·
Received December 7, 2022
Report
- Report Number
- 2017865-2022-48091
- Event Type
- Injury
- Date Received
- December 7, 2022
- Report Date
- October 23, 2023
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
- Product Code
- NVN
- PMA / PMN Number
- P960013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED.
Additional Manufacturer Narrative · 0
CORRECTION: H6 FOR PRODUCT NOT RETURNING.
Additional Manufacturer Narrative · 0
CORRECTION: SECTION D1 BRAND NAME SHOULD BE TENDRIL STS. SECTION D2 DEVICE PRODUCT CODE SHOULD BE NVN. SECTION D4 MODEL NUMBER SHOULD BE CORRECTED FROM UNK120702022-SY-05 TO 2088TC. SECTION G3 PMA NUMBER SHOULD BE P960013.
Description of Event or Problem · 0
RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2022-48092. IT WAS REPORTED THAT LEADS WERE DISLODGED CAUSING LOSS OF CAPTURE AND SENSING ON BOTH THE RIGHT VENTRICULAR (RV) LEAD AND THE ATRIAL (RA) LEAD. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE BOTH THE RV AND RA LEAD. THE PATIENT WAS RECOVERING AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2598267 | TENDRIL STS | LOW VOLTAGE LEADS | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC | ||
| 442309 | TENDRIL STS | LOW VOLTAGE LEADS | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 2088TC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |