FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1193448
·
Received October 7, 2008
Report
- Report Number
- 2182207-2008-06403
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 12, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
IT WAS REPORTED ELECTRODES 7 AND 15 ON EACH LEAD HAD LOW, OUT OF RANGE, IMPEDANCE VALUES. THE PATIENT HAD JUST BEEN IMPLANTED WITH A NEUROSTIMULATOR TO TREAT PAIN. THE DEVICE WAS SUCCESSFULLY REPROGRAMMED AVOIDING THE CONTACTS WITH THE SHORT CIRCUIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC NEUROMODULATION | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | UNK CONVERSION TYPE MODEL LEADN LOT #UNK| EXPLANTED| IMPLANTED |