FDA Adverse Event
Injury
Summary report: N
TENDRIL MRI
MDR report key: 9248218
·
Received October 28, 2019
Report
- Report Number
- 2938836-2019-15385
- Event Type
- Injury
- Date Received
- October 28, 2019
- Date of Event
- October 14, 2019
- Report Date
- December 14, 2019
- Manufacturer
- ABBOTT ELECTROPHYSIOLOGY
- Product Code
- NVN
- UDI-DI
- 05414734504683
- PMA / PMN Number
- P140033
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
Additional Manufacturer Narrative · 1
A CONNECTOR PORTION OF THE LEAD WAS RETURNED IN ONE PIECE MEASURING 18.7CM. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD EXHIBITED MULTIPLE EPISODES OF NOISE, WHICH WAS INHIBITING PACING. LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS RECOVERING AND DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1038326 | TENDRIL MRI | PERMANENT PACEMAKER ELECTRODE | NVN | ABBOTT ELECTROPHYSIOLOGY | LPA1200M/46 | A000037232 | 05414734504683 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |