FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2100321
·
Received May 16, 2011
Report
- Report Number
- 3004209178-2011-03564
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Report Date
- April 18, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING/JOLTING WHENEVER SHE MOVED WHILE THE STIMULATION WAS ON. THE PATIENT ONLY USED THE DEVICE FOR ONE YEAR AND WOULD LIKE IT REMOVED. ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB026449V| LEAD: MODEL 39565-30, LOT# N135718003| ACCESSORY: MODEL 37752, LOT# NKA036794N| EXTENSION: MODEL 37081, LOT# NJB026447V| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD064056N| IMPLANTED:| EXPLANTED: |