FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1953767
·
Received January 4, 2011
Report
- Report Number
- 3004209178-2011-00016
- Event Type
- Injury
- Date Received
- January 4, 2011
- Report Date
- December 17, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
SEE MANUFACTURER # 3004209178-2011-00015. THE PATIENT DEVELOPED AN INFECTION AND HAD THE DEVICE 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 | EXPLANTED:| EXPLANTED:| LEAD: MODEL 3487A, LOT #: J0406392V| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT #: NKE140635N| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT #: NJD021201N| ACCESSORY: MODEL 37752, LOT #: NKA016892N| EXTENSION: MODEL 37083, LOT #: NKC006824N| EXTENSION: MODEL 37083, LOT #: NKC006825N| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT #: J0406392V| LEAD: MODEL 3777, LOT #: N0030737| LEAD: MODEL 3777, LOT #: N0030737| EXPLANTED:| LOT #: NKF721956H| ACCESSORY: MODEL 37752, LOT #: NKA137847N| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712| IMPLANTED: |