FDA Adverse Event
Injury
Summary report: N
TENDRIL STS
MDR report key: 4231394
·
Received November 6, 2014
Report
- Report Number
- 2017865-2014-18191
- Event Type
- Injury
- Date Received
- November 6, 2014
- Date of Event
- September 26, 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
- SC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FLUOROSCOPY REVEALED THAT THE LEAD HAD DISLODGED; THE DATE OF THE DISCOVERY WAS NOT AVAILABLE. THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) 2014 AND IT WAS NOTED THAT THE LEAD EXHIBITED LOSS OF SENSING. THE PATIENT HAD DEVELOPED TWIDDLERS SYNDROME WHICH CONTRIBUTED TO THE LEAD DISLODGING. ON (B)(6) THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714645 | TENDRIL STS | PERMANENT PACEMAKER ELECTRODE | NVN | ST. JUDE MEDICAL, INC., CRMD | 2088TC/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | 7122Q/58, (B)(4) |