FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 3012266
·
Received March 12, 2013
Report
- Report Number
- 1627487-2013-15338
- Event Type
- Injury
- Date Received
- March 12, 2013
- Date of Event
- February 19, 2013
- Report Date
- February 19, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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: 1627487-2013-15339. IT WAS REPORTED THE PATIENT FEELS HIS LEADS HAVE MIGRATED AND ARE CAUSING HIM KIDNEY PAIN. THE PATIENT INDICATES X-RAYS WERE TAKEN THAT SHOWED ONE LEAD IS IN CLOSE PROXIMITY TO HIS IPG AND HAS MIGRATED TOWARDS THE AREA OF HIS KIDNEYS. THE PATIENT REQUESTED SURGICAL INTERVENTION BE TAKEN TO ADDRESS THIS ISSUE, BUT HIS PHYSICIAN DOES NOT WANT TO PERFORM ANY SURGICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 104566 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3183 | 3250316 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT DATE: |