FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2060948
·
Received March 14, 2011
Report
- Report Number
- 3004209178-2011-01900
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- January 1, 2009
- Report Date
- February 25, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE "4-POSITION" LEAD HAD FAILED AND ONLY 1 AND ONE HALF POSITIONS WORKED PART OF THE TIME. THE LEAD HAD NOT BEEN WORKING FOR OVER 2 YEARS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA034715N| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD059499N| UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXTENSION: MODEL 37083, LOT# NKC008620N| EXPLANTED: |