FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1895276
·
Received November 8, 2010
Report
- Report Number
- 3004209178-2010-09064
- Event Type
- Injury
- Date Received
- November 8, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 19, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PT'S PAIN STIMULATOR WAS ON, THE PT'S GASTRIC STIMULATOR WOULD NOT WORK AND THE PT'S STOMACH WOULD "BALLOON OUT." ALSO, THE PT HAD TO HAVE THE PAIN STIMULATOR TURNED UP SO HIGH THAT THE PT LOST CONTROL OF HER BLADDER. THE PAIN STIMULATOR HAD BEEN REPROGRAMMED BUT THIS DID NOT SOLVE THE PROBLEM. PER THE REPORTER, THE LOCATION OF THE PAIN STIMULATOR IMPLANT WAS "BAD" AS IT "STUCK OUT, WAS PAINFUL, AND CAUGHT ON THINGS. THE PAIN STIMULATOR WAS REMOVED DUE TO THE PT'S BACK "BEING LIKE DOMINOS."
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 | 63 YR | Required Intervention | PROGRAMMER: MODEL 37743, LOT# NKE138080N| IMPLANTED:| MODEL 3116, LOT# NHV104120H| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT010495N| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE PULSE GENERATOR:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132769N| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V363401020| EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT010491N |