FDA Adverse Event
Injury
Summary report: N
UNKNOWN SPINAL CORD STIMULATOR
MDR report key: 1220453
·
Received November 4, 2008
Report
- Report Number
- 2182207-2008-07191
- Event Type
- Injury
- Date Received
- November 4, 2008
- Date of Event
- October 9, 2008
- Report Date
- October 9, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS RETURNED FOR ANALYSIS. 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 THE PATIENT DID NOT FEEL ANY PARESTHESIA EVEN THOUGH THE VOLTAGE WAS INCREASED. THE IMPEDANCE WAS HIGHER THAN 4000 OHMS. THE PATIENT RETURNED TO OPERATING ROOM FOR FURTHER INVESTIGATION. DURING TESTING, THE VOLTAGE HAD REACHED 10 VOLTS WITH NO RESPONSE TO PARESTHESIA. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SPINAL CORD STIMULATOR | LGW | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | EXPLANTED:| LEAD: MODEL 3890 |