BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESIS

    MDR report key: 4091780 · Received August 28, 2014

    Report

    Report Number
    1627487-2014-08229
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    November 16, 2011
    Report Date
    April 2, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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.

    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

    INFO RECEIVED IDENTIFIED THE PT ALLEGES TO HAVE EXPERIENCED "BURNING AND SHOCKING SENSATIONS." FOR A LEGAL PRESERVATION NOTICE, THE PT'S SCS IPG WAS EXPLANTED AND REPLACED WITH A NEW MODEL IPG ON (B)(6) 2011. ADDITIONAL INFO IS NEEDED TO CLARIFY THE NATURE OF THE PT'S ISSUES. SJM WAS MADE AWARE OF THE ISSUES ON (B)(6) 2014 AND THE PT'S SCS SYSTEM WAS NOT EVALUATED BY THE SJM REP TO VERIFY AND/OR TROUBLESHOOT ANY OF THE REPORTED ISSUES PRIOR TO EXPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY FROM A REVIEW OF THE MEDICAL RECORD INDICATED THE PATIENT ALLEGES THE FOLLOWING ISSUES: SHORTLY AFTER IMPLANT (B)(6) 2005 CONFIRMED BY X-RAY, THE PATIENT'S SCS MIGRATED TO THE RIGHT CREATING PAIN AT THE IPG SITE; (B)(6) 2005 PATIENT UNDERWENT SURGICAL INTERVENTION TO REVISE THE IPG SITE; (B)(6) 2005-(B)(6) 2006, PATIENT STATES HER BATTERY WAS FLIPPING, MOVING AND SHOCKING HER AT THE IPG SITE; (B)(6) 2006 PATIENT UNDERWENT SURGICAL INTERVENTION REVISING THE IPG POCKET AND IMPLANTATION OF AN EXTENSION; (B)(6) 2007, PATIENT PRESENTED WITH STINGING AND BURNING PAIN AROUND THE BATTERY SITE AND WAS UNABLE TO LAY ON HER RIGHT SIDE; (B)(6) 2008 PATIENT UNDERWENT SURGICAL INTERVENTION TO REVISE THE IPG SITE; (B)(6) 2010, PATIENT STATED TO BE EXPERIENCING NAUSEA WHEN SHE USED HER SYSTEM; MOBILITY OF THE IPG AND FELT THE IPG WAS BECOMING MORE SUPERFICIAL; (B)(6) 2011 PATIENTS IPG IS EXPLANTED AND IMPLANTED WITH A SMALLER RECHARGEABLE BATTERY AS WELL AS REVISION OF LEAD CREATING A NEW POCKET ON THE LEFT LOWER BACK. POST OP THE PHYSICIAN NOTED THE ¿PATIENTS GENERATOR HAD MIGRATED FROM THE RIGHT FLANK TO THE RIGHT ABDOMINAL SUBCUTANEOUS LEVEL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526454 GENESIS SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3608 37941A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other IMPLANT DATE:| SCS LEAD: MODEL 3208| SCS EXTENSION: MODEL 3383