BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 4840534 · Received June 12, 2015

    Report

    Report Number
    1627487-2015-06262
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 21, 2015
    Report Date
    June 15, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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

    (B)(4). 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

    ADDITIONAL INFORMATION RECEIVED IDENTIFIED SURGICAL INTERVENTION TOOK PLACE ON (B)(6) 2015. DURING THE SURGERY THE PATIENT'S LEADS WERE REPOSITIONED (REFERENCE MFR. REPORT # 1627487-2015-06258; 1627487-2015-06259; 1627487-2015-06260; 1627487-2015-06261), HOWEVER, NOTHING WAS DONE WITH THE PATIENT'S IPG. POSTOPERATIVE, THE PATIENT STATED THE PAIN AT THE IPG SITE HAD RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AT HER SCS IPG SITE WHICH IS CAUSING HER TO HAVE DIFFICULTY SLEEPING. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385637 PROTEGE IPG, 16-CHANNEL RECHARGEABLE SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3789 4898680

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other MODEL 3341 (X2), SCS EXTENSION| MODEL 3166 (X4), SCS LEAD