FDA Adverse Event
Malfunction
Summary report: N
1X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION
MDR report key: 1885253
·
Received October 25, 2010
Report
- Report Number
- 3007566237-2010-08397
- Event Type
- Malfunction
- Date Received
- October 25, 2010
- Date of Event
- June 28, 2010
- Report Date
- June 28, 2010
- 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
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OR PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY, WHEN REMOVING THE EXTENSION FROM THE STIMULATOR, IT WAS FOUND THAT THE BOTTOM PRONG WAS STRIPPED SLIGHTLY ELONGATING AND EXPOSING SOME COIL. IMPEDANCE LEVELS WERE TESTED AND WERE NORMAL. IT WAS UNCLEAR WHETHER THE EXTENSION WAS USED FURTHER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1X4 POCKET ADAPTOR FOR SPINAL CORD STIMULATION | LGW | MEDTRONIC NEUROMODULATION | 74001 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |