FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2073612
·
Received April 27, 2011
Report
- Report Number
- 3004209178-2011-03137
- Event Type
- Injury
- Date Received
- April 27, 2011
- Report Date
- March 28, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT DEVELOPED A (B)(6) INFECTION AND BLOOD CLOTS. THE DEVICE WAS REMOVED. ADDITIONAL INFORMATION 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 | Required Intervention | IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA123838N| LEAD: MODEL 3778, LOT # V182323005| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT # V177008037| PROGRAMMER: MODEL 37743, LOT # NKE122288N| EXPLANTED: |