FDA Adverse Event
Injury
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2210544
·
Received August 10, 2011
Report
- Report Number
- 3004209178-2011-06236
- Event Type
- Injury
- Date Received
- August 10, 2011
- Date of Event
- January 1, 2010
- Report Date
- April 21, 2011
- Manufacturer
- MEDTRONIC 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 STIMULATOR WAS FLIPPING, SO A SMALLER STIMULATOR WAS IMPLANTED. FOR FURTHER INFORMATION ABOUT WHAT HAPPENED AFTER THE REPLACEMENT, REFER TO MFR REPORT #3004209178201103647.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention | PROGRAMMER: MODEL 37742, LOT# NJD043356N| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC007717N| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB071902V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB071901V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37712| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# V012411| EXTENSION: MODEL 37083, LOT# NKC018489N |