FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2102358
·
Received May 20, 2011
Report
- Report Number
- 3004209178-2011-03709
- Event Type
- Malfunction
- Date Received
- May 20, 2011
- Date of Event
- March 30, 2011
- Report Date
- April 25, 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
THE PATIENT EXPERIENCED SHOCKING AND PINCHING ON HER RIGHT SIDE WHEN HER STIMULATION WAS TURNED ON. THE SHOCKING STARTED WHEN THE STIMULATOR WAS TURNED UP TO ABOUT 3.0 V BUT WAS NOT PRESENT AT LOWER LEVELS. REPROGRAMMING TO USE FEWER ELECTRODES ON THE LEAD STILL RESULTED IN SHOCKING AT HIGHER VOLTAGES. THE PATIENT HAD BEEN EXPERIENCING THIS SHOCKING AND PINCHING SINCE IMPLANT. IMPEDANCES WERE MEASURED AND WERE WITHIN NORMAL RANGES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 56 YR | IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V550634003| IMPLANTED:| LEAD: MODEL 3777, LOT# V527884019| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE164580N| ACCESSORY: MODEL 37752, LOT# NKA147826N |