FDA Adverse Event
Malfunction
Summary report: N
OCTRODE
MDR report key: 3142838
·
Received May 24, 2013
Report
- Report Number
- 1627487-2013-03696
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- May 1, 2013
- Report Date
- May 1, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-03697. IT WAS REPORTED, THE PT IS NOT RECEIVING EFFECTIVE STIMULATION DUE TO HER PROGRAMS AUTO-REDUCING. LEAD DIAGNOSTICS SHOWED INVALID IMPEDANCE VALUES FOR THE SCS LEAD. X-RAYS ARE TO BE TAKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 232921 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3183 | 3376663 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT DATE: |