FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2030446
·
Received March 9, 2011
Report
- Report Number
- 3004209178-2011-01796
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Report Date
- February 23, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- 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
RECEIVED INFO THE PT WAS WALKING IN HIS HOUSE ABOUT THREE WEEKS AGO AND EXPERIENCED AN INCREASE IN STIMULATION AND THEN CHANGE IN RATE WENT FROM TAPPING TO EXTREMELY SMOOTH AND THEN NO STIMULATION SENSATION. THEN IS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT. MFR'S REP INTERROGATED THE DEVICE AND IMPEDANCES ARE NORMAL. AFTER THE PT LOST STIMULATION, HE WENT TO RECHARGE AND EXPERIENCED A SHOCKING SENSATION IN HIS LEG. PT DID NOT BRING IN HIS RECHARGER OR PT PROGRAMMER SO THE REP WAS NOT ABLE TO TROUBLESHOOT THE DEVICES. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, A F/U REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | PROGRAMMER: MODEL 37743, LOT# NKE160157N| LEAD: MODEL 39565-65, LOT# V531206046| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA148488N| EXPLANTED: |