FDA Adverse Event
Malfunction
Summary report: N
N/A
MDR report key: 3071756
·
Received April 22, 2013
Report
- Report Number
- 3004209178-2013-06710
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- February 8, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- OTHER
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).
Description of Event or Problem · 1
IT WAS REPORTED BY PATIENT'S SON THAT PATIENT WAS NOT FEELING WELL. FOLLOW-UP WAS CONDUCTED TO OBTAIN INFORMATION ON THE PATIENT AND WHETHER THE EVENT WAS DEVICE RELATED, BUT THE PATIENT HAD NOT BEEN SEEN BY THE PHYSICIAN IN SEVERAL YEARS. RECORDS INDICATE THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171943 | N/A | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | VEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5076 X2 IMPLANTABLE PACING LEADS |