BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 2191127 · Received July 29, 2011

    Report

    Report Number
    1627487-2011-00949
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K090907
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED PAST THE 30-DAY REPORTING REQUIREMENT AS PART OF AN ADDITIONAL RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO THE (B)(6) 2011 FDA INSPECTION. WE ARE SUBMITTING THIS MDR AS THE RESULT OF A RE-EVALUATION OF OUR COMPLAINT PROCESS. 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

    THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND SURGICAL LEAD ON (B)(6) 2011 FOR LEG AND BACK PAIN. IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING HEART PALPITATIONS SINCE IMPLANT. ALTHOUGH THE PATIENT EXPERIENCED PALPITATIONS BEFORE RECEIVING THE SCS SYSTEM, THE ISSUE HAS REPORTEDLY INCREASED IN INTENSITY AND IS SAID TO BE PRESENT REGARDLESS OF THE STIMULATION'S FUNCTION. EFFORTS TO RESOLVE THIS MATTER VIA REPROGRAMMING HAVE BEEN UNSUCCESSFUL THUS FAR. FOLLOW-UP ON THIS ISSUE FOUND THAT A RECENT X-RAY SHOWS THAT THE PATIENT'S LEAD HAS MIGRATED. AN APPOINTMENT HAS BEEN SCHEDULED WITH THE IMPLANTING PHYSICIAN TO DETERMINE THE NEXT COURSE OF ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 3MM LEAD, 60 CM SPINAL CORD STIMULATION LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 3300294

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS IPG, MODEL: 3788| SCS LEAD ANCHOR, MODEL 1194| SCS LEAD ANCHOR, MODEL 1194| IMPLANTED: