FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1910989
·
Received November 23, 2010
Report
- Report Number
- 3004209178-2010-09898
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- October 8, 2010
- Report Date
- November 17, 2010
- 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
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE DEVICE HAD BEEN INTERROGATED AT SOME POINT PRIOR TO (B)(6) 2010 AND IMPEDANCES WERE ALL IN THE GREATER 2,000 OHM RANGE. THE PT UNDERWENT SURGERY FOR IPG REPLACEMENT. AT F/U ON (B)(6) 2010, THE PT HAD EXCELLENT COVERAGE IN BOTH HIS UPPER AND LOWER EXTREMITIES.
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 | 62 YR | Required Intervention | EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE122721N| LEAD: MODEL 39565-30, LOT# N171076001| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA120198N| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB049456V| EXTENSION: MODEL 37081, LOT# NJB049458V| IMPLANTED: |