FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1231092
·
Received October 30, 2008
Report
- Report Number
- 3004209178-2008-07024
- Event Type
- Malfunction
- Date Received
- October 30, 2008
- Date of Event
- September 1, 2008
- Report Date
- October 3, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT WAS EXPERIENCING INTERMITTENT STIMULATION FOR ABOUT A WEEK. THE PT HAD EXPERIENCED A SHOCK ABOUT A WEEK PRIOR WHILE DRIVING BY A POWER PLANT. SINCE THAT TIME THE STIMULATION ON PROGRAM ONE HAS BEEN INTERMITTENT. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777| LEAD: MODEL 3777 |