FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1831842
·
Received September 8, 2010
Report
- Report Number
- 3004209178-2010-06860
- Event Type
- Malfunction
- Date Received
- September 8, 2010
- Report Date
- August 11, 2010
- 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
A PATIENT'S DEVICE WAS HAVING TELEMETRY ISSUES, IN WHICH A POWER ON RESET CONDITION OCCURRED. NO FURTHER DETAILS IN REGARDS TO THE ISSUE WERE REPORTED, INCLUDING THE PATIENT'S STATUS/OUTCOME. ADDITIONAL INFORMATION IS BEING REQUESTED, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| IMPLANTED:| LEAD: MODEL#3777, LOT #V034485039| PROGRAMMER: MODEL #37742, LOT #NJD048794N| EXPLANTED:| EXPLANTED:| LEAD: MODEL #3777, LOT #V035457019| EXPLANTED:| ACCESSORY: MODEL #37752, LOT #NKA030168N| EXPLANTED:| IMPLANTED:| IMPLANTED: |