FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1098648
·
Received August 5, 2008
Report
- Report Number
- 6000032-2008-04655
- Event Type
- Malfunction
- Date Received
- August 5, 2008
- Date of Event
- July 8, 2008
- Report Date
- July 8, 2008
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, MED REL
- 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
Description of Event or Problem · 1
IMPEDANCE READING >4000 OHMS WAS REPORTED ON ALL OR SOME OF THE BIPOLAR PAIRS. ELECTRODES 4-7 WERE NOT PROGRAMMED. THE NEUROSTIMULATOR WAS DEPLETED. THE DEVICE WAS REPLACED. IMPEDANCES WERE NORMAL. THE STIMULATION WAS SATISFACTORY TO THE PT POST-OPERATIVELY. REFER TO MFR REPORT #6000032-2008-04656.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO, MED REL | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3986ILC| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7427V| EXPLANTED:| LEAD: MODEL 3986| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986ILC| EXPLANTED:| EXTENSION: MODEL 7496-66| EXTENSION: MODEL 7495-51| IMPLANTED:| LOT#NFE403684H| IMPLANTED:| EXPLANTED: |