FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1981391
·
Received February 1, 2011
Report
- Report Number
- 3004209178-2011-00774
- Event Type
- Malfunction
- Date Received
- February 1, 2011
- Date of Event
- August 1, 2010
- Report Date
- January 18, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT HAS NOT HAD THERAPEUTIC STIMULATION SINCE IMPLANT. IN (B)(4) 2010, A SECOND LEAD WAS IMPLANTED AND STILL PATIENT STATES HE DOESN'T HAVE THERAPEUTIC STIMULATION. THE PATIENT PROGRAMMER WAS REVIEWED WITH THE PATIENT BY MEDTRONIC PATIENT SERVICES, PROGRAM 1 AT 7.0 & PROGRAM 2 AT 6.0. PATIENT STATES HE FEELS STIMULATION BUT THE PAIN IS STILL PRESENT. PATIENT WAS INSTRUCTED TO SEE HIS HCP REGARDING LACK OF PAIN RELIEF AND POSSIBLE REPROGRAMMING.
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 | 76 YR | EXPLANTED: UNK| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA138291N| LEAD: MODEL 3776, LOT # V381516034| LEAD: MODEL 39286-65, LOT # V465075019| PROGRAMMER: MODEL 37743, LOT# NKE145626N| EXPLANTED: UNK| LEAD: MODEL 3776, LOT # V244372013| EXPLANTED: UNK| IMPLANTED: |