FDA Adverse Event
Malfunction
Summary report: N
UNK
MDR report key: 1080257
·
Received July 22, 2008
Report
- Report Number
- 2182207-2008-04240
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 24, 2008
- Report Date
- June 24, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE ANCHOR 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 DURING THE REPLACEMENT SURGERY OF THE NEUROSTIMULATOR, THE LEAD WAS DISLOCATED IN THE EPIDURAL SPACE BECAUSE THE OUTER SILICONE SLEEVE OF THE ANCHOR WAS LOOSE FROM THE INNER TITANIUM ANCHORING BODY. THE LEAD WAS REPOSITIONED AND THE ANCHOR WAS REPLACED WITH A NEW ONE. THE PT WAS FINE AFTER SURGERY AND RECEIVED GOOD PARESTHESIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | LGW | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED| EXPLANTED| ACCESSORY MODEL 3550-39 LOT#B0380531K |