FDA Adverse Event
Malfunction
Summary report: N
SINGLE EXTENSION
MDR report key: 2770713
·
Received October 1, 2012
Report
- Report Number
- 1627487-2012-00651
- Event Type
- Malfunction
- Date Received
- October 1, 2012
- Date of Event
- September 6, 2012
- Report Date
- September 6, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2, REFERENCE MFR REPORT # 1627487-2012-00650. IT WAS REPORTED THE PT (B)(6) LOST STIMULATION. A DIAGNOSTIC TEST FOUND IMPEDANCE ISSUES FOR SEVERAL LEAD CONTACTS. EFFORTS TO RECAPTURE EFFECTIVE STIMULATION UTILIZING THE FUNCTIONAL CONTACTS WAS UNSUCCESSFUL. A DECISION REGARDING THE NEXT COURSE OF ACTION HAS NOT BEEN REACHED..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SINGLE EXTENSION | SCS EXTENSION | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3383 | 3737186 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | SCS IPG: MODEL 3688| IMPLANT: |