FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1872526
·
Received October 12, 2010
Report
- Report Number
- 3004209178-2010-07834
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- May 1, 2010
- Report Date
- September 14, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION, WHILE THE DEVICE WAS TURNED ON, BEGINNING A WEEK AFTER THE DEVICE WAS IMPLANTED. X-RAYS WERE PERFORMED AND NO VISIBLE ISSUES WERE SEEN. NO FURTHER DETAILS OR PT OUTCOME WERE PROVIDED. ADD'L INFO WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADD'L INFO 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 | 34 YR | STIM ACCESSORY: MODEL 3550-39, LOT#: N244112| IMPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT#: NKE146833N| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT#: N232428| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT#: V408720014| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT#: NKA138428N| EXPLANTED:| EXTENSION: MODEL 37081, LOT#: NJB072798V |