FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2050047
·
Received March 31, 2011
Report
- Report Number
- 3004209178-2011-02453
- Event Type
- Malfunction
- Date Received
- March 31, 2011
- Report Date
- March 14, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT WAS SCHEDULED FOR A REVISION ON (B)(6) 2011 DUE TO THE LEAD "MAY" HAVE MIGRATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V639158031| LEAD: MODEL 3778, LOT# V639158032| ACCESSORY: MODEL 37752, LOT# NKA151010N| PROGRAMMER: MODEL 37743, LOT# NKE164008N| IMPLANTED: |