FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2021789
·
Received February 25, 2011
Report
- Report Number
- 3004209178-2011-01456
- Event Type
- Injury
- Date Received
- February 25, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 9, 2011
- 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED INTERMITTENT STIMULATION. HE NOTED THAT HE HAD SEVERAL FALLS SINCE THE NEUROSTIMULATOR WAS IMPLANTED AND COULD NOT ATTRIBUTE ANY OF THEM TO THE INTERMITTENT STIMULATION EVENT. ADD'L INFO WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Male | ACCESSORY: MODEL 37752, LOT# NKA025212N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V016057| LEAD: MODEL 3777, LOT# V016057| PROGRAMMER: MODEL 37742, LOT# NJD038216N| ACCESSORY: MODEL 37752, LOT# NKA025212N| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V016057| LEAD: MODEL 3777, LOT# V016057| PROGRAMMER: MODEL 37742, LOT# NJD038216N| IMPLANTED:| IMPLANTED: |