FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1924825
·
Received December 9, 2010
Report
- Report Number
- 3004209178-2010-10356
- Event Type
- Injury
- Date Received
- December 9, 2010
- Date of Event
- January 1, 2010
- Report Date
- December 1, 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
- PA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THERE WERE COUPLING/COMMUNICATION ISSUES DURING RECHARGING AND THE STIMULATION COULD NOT BE ADJUSTED. THE PT UNDERWENT A BATTERY REPLACEMENT (NO DETAILS WERE PROVIDED). FURTHER INFO IS BEING REQUESTED FROM THE HCP.
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 | 40 YR | Required Intervention | IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE154199N| ACCESSORY: MODEL 37752, LOT# NKA144380N| LEAD: MODEL 39565-65, LOT# V373309026| EXPLANTED: |