FDA Adverse Event
Malfunction
Summary report: N
ITREL3
MDR report key: 2031349
·
Received March 16, 2011
Report
- Report Number
- 3004209178-2011-02004
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Report Date
- February 22, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT INDICATED THE "IMPLANT" FAILED AS THE LEADS WERE BROKEN. THE PATIENT REPORTED SHE HAD "3 FAILED IMPLANTS DUE TO BROKEN LEADS." (REFER TO MANUFACTURER'S REPORT # 3007566237201101735 AND 3004209178201102003). TESTING WAS DONE, ALTHOUGH THE TYPE AND RESULTS OF THE TEST WERE NOT REPORTED. THE PATIENT HAD DIFFICULTIES FINDING A PHYSICIAN TO EXPLANT THE SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ITREL3 | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7425 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXTENSION: MODEL 7495-66, LOT# XS0003723N| EXPLANTED:| PROGRAMMER: MODEL 7434, LOT# YN0022170P| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3587A, LOT# L54739| IMPLANTED: |