FDA Adverse Event
Malfunction
Summary report: N
RESTORE USA
MDR report key: 1884848
·
Received October 15, 2010
Report
- Report Number
- 3004209178-2010-07994
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- September 1, 2010
- Report Date
- September 18, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THIS OCCURRED FOLLOWING A POSITION CHANGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE USA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | EXTENSION: MODEL 37082, LOT# NKB005223V| LEAD: MODEL 3999, LOT# V032562| PROGRAMMER: MODEL 37743, LOT# NKE144470N| ACCESSORY: MODEL 37752, LOT# NKA137680N| IMPLANTED:| LEAD: MODEL 3999, LOT# V159089| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB005063V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED: |