FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME ADVANCED
MDR report key: 2143005
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04727
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 27, 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
THE PT FELT STIMULATION IN THE WRONG LOCATION. A LEAD REVISION WAS PERFORMED. THE REASON FOR THE REVISION WAS NOT PROVIDED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
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 | 36 YR | Required Intervention | LEAD: MODEL 3778, LOT# V558088029| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V558088030| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE156651N |