FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 2212615
·
Received August 11, 2011
Report
- Report Number
- 3004209178-2011-06270
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- April 8, 2010
- Report Date
- July 18, 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 HAD DIFFICULTY RECHARGING AND THEREFORE HAD THE ENTIRE DEVICE SYSTEM EXPLANTED. THE DEVICE WAS REPLACED WITH A NON-RECHARGEABLE.
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 | 79 YR | Required Intervention | EXTENSION: MODEL 37083, LOT # NKC001904V| LEAD: MODEL 3888, LOT # V354745| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE136624N| ACCESSORY: MODEL 37752, LOT # NKA131575N| IMPLANTED:| EXTENSION: MODEL 37082, LOT # NKB003300V| LEAD: MODEL 3888, LOT # V354745| EXPLANTED: |