FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1800108
·
Received August 11, 2010
Report
- Report Number
- 3004209178-2010-06023
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- July 12, 2010
- Report Date
- July 12, 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
THE HCP WAS UNABLE TO INSERT THE LEAD INTO THE HEADER BLOCK OF THE IMPLANTABLE NEUROSTIMULATOR, PORT 0-7. THEY WERE ABLE TO INSERT IT INTO 8-15. DEVICE REGISTRATION SHOWS A DIFFERENT NEUROSTIMULATOR WAS IMPLANTED. NO ADDITIONAL CLINICAL INFO WAS REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE149880N| LEAD: MODEL 3776, LOT # V468787035| LEAD: MODEL 3776, LOT # V472988007| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA142051N| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712,| LOT # NKF724101H| IMPLANTED: |