FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2053642
·
Received March 1, 2011
Report
- Report Number
- 3004209178-2011-01535
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- January 1, 2010
- Report Date
- February 14, 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 THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, AND HIGH IMPEDANCES WERE REPORTED. IT WAS STATED THAT IMPEDANCES OF >40,000 OHMS WERE MEASURED. IT WAS STATED THE PT HAD FALLEN "A FEW MONTHS AGO" AND THAT MAY HAVE CAUSED THE PROBLEM. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO 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 | 84 YR | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3999, LOT# V124492| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE142002N| IMPLANTED:| LEAD: MODEL 3888, LOT# V346982| IMPLANTED:| STIM ACCESSORY: MODEL 37092, LOT# 231260001| EXTENSION: MODEL 37082, NKB004601V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V186426| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB002239V |