FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1963487
·
Received December 20, 2010
Report
- Report Number
- 3004209178-2010-10594
- Event Type
- Malfunction
- Date Received
- December 20, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 7, 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
- WY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INFO RECEIVED REPORTS THE PT FELL A FEW DAYS AGO AND NOW HIS STIMULATION IS NOT AS EFFECTIVE ON HIS BONE PAIN AS IT WAS PRIOR TO THE FALL. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | PROGRAMMER: MODEL 37743, LOT# NKE150737N| ACCESSORY: MODEL 37752, LOT# NKA135921N| LEAD: MODEL 39286-65, LOT# V456863019| IMPLANTED:| EXPLANTED: |