FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2223863
·
Received August 18, 2011
Report
- Report Number
- 3004209178-2011-06504
- Event Type
- Injury
- Date Received
- August 18, 2011
- Date of Event
- January 1, 2011
- Report Date
- July 26, 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
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT COULD NOT FEEL A STIMULATION SENSATION. THE PT'S COLON WAS "GOING CRAZY" AND THE PT DEVELOPED ABDOMINAL INFECTIONS. THE PT WAS IN FAIR CONDITION. IT WAS NOTED THAT THE LEAD WAS MALFUNCTIONING AND CAUSING PAIN. THE PT WAS GOING TO SCHEDULE A REVISION. ADDITIONAL INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE PRIME ADVANCED | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37702 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention | EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE113542N| LEAD: MODEL 3777, LOT# V111861029| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB014286V |