FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2190430
·
Received July 25, 2011
Report
- Report Number
- 3004209178-2011-05773
- Event Type
- Injury
- Date Received
- July 25, 2011
- Report Date
- June 29, 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 PT WAS IN AN ACCIDENT AND "4 LEADS CAME OUT." THE PT WAS IN A GREAT DEAL OF PAIN AND NEEDED SURGERY TO FIX THE ISSUE. THE PT WAS IN FAIR STATUS. ADDITIONAL INFO INDICATED THAT THE PHYSICIAN DECIDED TO REPLACE THE LEADS; NO INFO REGARDING THIS PROCEDURE HAS BEEN RECEIVED. ADDITIONAL INFO WAS REQUESTED FROM THE PT'S PHYSICIAN.
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:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V533957009| PROGRAMMER: MODEL 37743, LOT# NKE158523N| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA148621N |