BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 2934124 · Received January 3, 2013

    Report

    Report Number
    1627487-2013-04008
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    September 6, 2012
    Report Date
    December 21, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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.

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DID NOT HAVE STIMULATION WHERE IT WAS NEEDED. THE PT REPORTED THE STIMULATION WAS IN THE FRONT OF THE LEGS SINCE IMPLANT, AND THERE WAS NO STIMULATION IN THE BACK OF HER LEGS. REPROGRAMMING HAD BEEN UNABLE TO PROVIDE COVERAGE. THE NEXT COURSE OF ACTION WAS UNDETERMINED.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW OF THE PATIENT'S MEDICAL RECORD IDENTIFIED ON (B)(6) 2012 THE PATIENT PRESENTED WITH INEFFECTIVE PAIN RELIEF. X-RAYS INDICATED THE LEAD WAS MIGRATED AND THE PATIENT HAD STOPPED USING HER SCS SYSTEM. THE PATIENT'S SCS SYSTEM WAS EXPLANTED ON (B)(6) 2015 AS REPORTED EARLIER.

    Description of Event or Problem · 1

    FURTHER FOLLOW UP IDENTIFIED THE SCS LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4030 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3456416

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE: