FDA Adverse Event
Injury
Summary report: N
TENDRIL SDX LEAD
MDR report key: 5150272
·
Received October 14, 2015
Report
- Report Number
- 2017865-2015-29418
- Event Type
- Injury
- Date Received
- October 14, 2015
- Date of Event
- September 26, 2015
- Report Date
- September 26, 2015
- 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
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A POST-OPERATIVE EXAMINATION ONE DAY POST IMPLANT, X-RAY REVEALED THAT THE RIGHT ATRIAL LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED WITHOUT ISSUE ON (B)(6) 2015. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678676 | TENDRIL SDX LEAD | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | 1688TC/46 | P000009115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 93 YR | Required Intervention |