FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2231128
·
Received August 26, 2011
Report
- Report Number
- 3004209178-2011-06924
- Event Type
- Injury
- Date Received
- August 26, 2011
- Date of Event
- August 12, 2011
- Report Date
- August 12, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WENT INTO THE OPERATING ROOM FOR A LEAD REVISION. DURING RECOVERY THE NURSE WENT TO PROGRAM THE PATIENT AND AN ELECTIVE REPLACEMENT INDICATOR MESSAGE APPEARED. ADDITIONAL INFORMATION 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 | 60 YR | Required Intervention | PROGRAMMER: MODEL 37743, LOT# NKE155369N| LEAD: MODEL 3777, LOT# V493924026| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V493924015 |