FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2032490
·
Received March 23, 2011
Report
- Report Number
- 3004209178-2011-02242
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- August 2, 2010
- Report Date
- March 9, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- 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 DEVELOPED AN INFECTION AND THE DEVICE SYSTEM WAS REMOVED. ADD'L INFO HAS BEEN REQUESTED.
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 | 46 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 3778, LOT# V490056011| LEAD: MODEL 3778, LOT# V490056012| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE151308N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA142031N |