FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2060934
·
Received March 14, 2011
Report
- Report Number
- 3004209178-2011-01891
- Event Type
- Malfunction
- Date Received
- March 14, 2011
- Date of Event
- February 28, 2011
- Report Date
- February 28, 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 EXPERIENCED A SHOCKING SENSATION WHEN HE TURNED HIS DEVICE ON FOR THE FIRST TIME. THEN STIMULATOR WAS SET ON 3.8V. PATIENT STATED HE WOULD TURN THE STIMULATION TO 0.V BEFORE HE TURNS IT ON AGAIN. HE HAS NOT BEEN TRAINED YET AND HAS AN APPOINTMENT ON FRIDAY TO SEE THE MANUFACTURER'S REPRESENTATIVE AND HIS DOCTOR FOR THE TRAINING. PATIENT WILL WAIT UNTIL TRAINING TO TURN HIS DEVICE BACK ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
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 | 54 YR | IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE161263N| LEAD: MODEL 39565-65, LOT# V592240004| ACCESSORY: MODEL 37752, LOT# NKA149843N| EXPLANTED: |