FDA Adverse Event
Malfunction
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2030889
·
Received March 4, 2011
Report
- Report Number
- 3004209178-2011-01640
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 17, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
IT WAS REPORTED THE PT FELL AND WAS NO LONGER RECEIVING STIMULATION IN HIS LEFT LOWER LEG. AN X-RAY WAS PERFORMED, BUT THE RESULTS WERE NOT KNOWN. THE IMPEDANCES WERE CHECKED AND ALL WERE WITHIN NORMAL LIMITS. THE STIMULATOR WAS REPROGRAMMED AND THE PT WAS ABLE TO GET COVERAGE BACK IN HIS LEFT LOWER LEG. THE REPROGRAMMING REQUIRED A SIGNIFICANT INCREASE IN AMPLITUDE, FROM 4.2 TO 8.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | ACCESSORY: MODEL 3550-4, LOT# N255526| IMPLANTED:| LEAD: MODEL 3777, LOT# V550634007| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE155077N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V550634004| EXPLANTED:| EXPLANTED: |