FDA Adverse Event
Malfunction
Summary report: N
SENSIA
MDR report key: 2953725
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-02039
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 16, 2012
- Report Date
- February 22, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE SETSCREW WAS NO POSITION PROPERLY WHICH RESULTED IN OUT OF RANGE IMPEDANCE. FLUOROSCOPY SHOWED THAT THE LEAD PIN WAS NOT PAST THE SETSCREW. AFTER RE-INSERTING THE LEAD PROPERLY, THE DEVICE MEASURED NORMAL IMPEDANCE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55983 | SENSIA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | SESR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR | 5076-58 IMPLANTABLE PACING LEAD |