FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 2250666
·
Received September 13, 2011
Report
- Report Number
- 3004209178-2011-07784
- Event Type
- Injury
- Date Received
- September 13, 2011
- Date of Event
- January 1, 2007
- Report Date
- October 18, 2007
- 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LEAD "ISSUE," AND, THEREAFTER, DID NOT USE THE IMPLANTABLE NEUROSTIMULATOR. THE DEVICE WAS KEPT RECHARGED, HOWEVER. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A FAILURE OF PAIN CONTROL. IT WAS NOTED THAT A "LEAD FAILURE" HAD OCCURRED. THERE WAS AN IMPEDANCE "ISSUE" WITH ELECTRODE #2. NO FURTHER DETAILS WERE PROVIDED. IT WAS LATER REPORTED THAT THE PATIENT'S LEADS AND EXTENSIONS WERE REMOVED. NO INFORMATION WAS PROVIDED RELATED TO THE PATIENT'S OUTCOME. 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 RECHARGABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC004722N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT# N0053128| ACCESSORY: MODEL 37752, LOT# NKA016169N| PROGRAMMER: MODEL 37742, LOT#NJD021367N| EXPLANTED:| LEAD: MODEL 3986A, LOT# N0053128| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC004725N |