FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1840787
·
Received September 17, 2010
Report
- Report Number
- 3004209178-2010-07093
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- August 1, 2010
- Report Date
- September 1, 2010
- 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
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION AT THE STIMULATOR LOCATION ONLY WHILE THE STIMULATION WAS TURNED ON. THE SYMPTOMS OCCURRED FOLLOWING IMPLANT. IMPEDANCE MEASUREMENTS WERE NORMAL. NO PT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 68 YR | PROGRAMMER: MODEL 37743, LOT# NKE152633N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3586, LOT# LW0015333N| ADAPTER: MODEL 74001, LOT# N257293| EXPLANTED:| EXTENSION: MODEL 7496-51, LOT# YR0014052N| ACCESSORY: MODEL 37752, LOT# NKA139329N| IMPLANTED: |