FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1953506
·
Received January 5, 2011
Report
- Report Number
- 3004209178-2011-00060
- Event Type
- Injury
- Date Received
- January 5, 2011
- Date of Event
- April 1, 2010
- Report Date
- July 27, 2009
- 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
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THIS REPORT IS BEING SUBMITTED FOLLOWING INTERNAL AUDIT.
Description of Event or Problem · 1
THE PT EXPERIENCED STIMULATION IN THE WRONG LOCATION. HER STIMULATION WAS FELT IN HER CHEST AND WAS NOT COVERING THE PAIN. SHE HAD AN APPOINTMENT WITH HER PHYSICIAN ON APRIL 23RD. SHE WAS AT HOME IN FAIR CONDITION. THE HEALTH CARE PROVIDER CONFIRMED THAT THE PT EXPERIENCED A LACK OF EFFECT. THE DEVICE WAS EXPLANTED AND PT OUTCOME WAS NOTED AS NO INJURY.
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 | 43 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 39565, LOT# N179882001| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB047122V| PROGRAMMER: MODEL 37743, LOT# NKE125197N| ACCESSORY: MODEL 37752, LOT# NKA121978N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB053634V| IMPLANTED:| EXPLANTED:| IMPLANTED: |