FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1870462
·
Received October 11, 2010
Report
- Report Number
- 3004209178-2010-07811
- Event Type
- Injury
- Date Received
- October 11, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 18, 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE PATIENT HAD A POCKET REVISION, AFTER WHICH THE PATIENT HAD "MINIMAL STIMULATION" FROM THEIR DEVICE. IT WAS REPORTED THAT, SOMETIME AFTER, THERE WAS A LOSS OF STIMULATION, WITH IMPEDANCES ON THE DEVICE AT >40,000 OHMS. THE REASON FOR THE POCKET REVISION WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 51 YR | Required Intervention | EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT #NKE127726N| LEAD: MODEL 3777, LOT #V259300003| EXTENSION: MODEL 37081, LOT #NJB72748V| IMPLANTED:| IMPLANTED: |