FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 1123813
·
Received August 15, 2008
Report
- Report Number
- 3004209178-2008-04993
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- July 1, 2008
- Report Date
- July 21, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE DISPLAY SHOWED "CALL YOUR DOCTOR" ICON AND ERI. SEVERAL DAYS LATER, THE DEVICE SHOWED AN EOS MESSAGE. THE PATIENT HAD TWO DIFFERENT PROGRAMS, 5.8V@300 AND 360 PULSE WIDTH AND A RATE OF 50. THE DEVICE HAD BEEN IMPLANTED FOR 45 DAYS. NO OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| EXPLANTED:| LEAD MODEL 3776| LEAD MODEL 3776| EXPLANTED:| PROGRAMMER MODEL 37743| IMPLANTED: |