FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2152268
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04690
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- April 18, 2011
- Report Date
- May 25, 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
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION, FOLLOWING AN UNRELATED BACK SURGERY PERFORMED ON (B)(6) 2011. THE SENSATION WAS NOT SPECIFIC TO ONLY ONE SIDE OF THE PATIENT. THE PATIENT HAD FOUR PROGRAMS, ONE OF WHICH SEEMED TO PRODUCE AN INTERMITTENT SHOCKING SENSATION IF THE PATIENT'S HEAD WAS PLACED IN A CERTAIN POSITION. THE OTHER THREE PROGRAMS PROVIDED A CONTINOUS SHOCKING SENSATION. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED 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 | 70 YR | IMPLANTED:| RECHARGER: MODEL 37752, LOT# NKA111670N| LEAD: MODEL 3487A, LOT# V093277| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC015571N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC016295N| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V076376 |