FDA Adverse Event
Malfunction
Summary report: N
ADDR01
MDR report key: 2951757
·
Received February 9, 2013
Report
- Report Number
- 3004209178-2013-01598
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- October 27, 2012
- Report Date
- November 5, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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. CONCOMITANT PRODUCT: 5034 IMPLANTABLE PACING LEAD (B)(6) 1999. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED APPROXIMATELY 20 MONTHS AFTER THE USE BEFORE DATE. THE DEVICE IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 57423 | ADDR01 | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00088 YR | 4568 IMPLANTABLE PACING LEAD |