BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY IPG

    MDR report key: 6884565 · Received September 21, 2017

    Report

    Report Number
    1627487-2017-05282
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    September 5, 2017
    Report Date
    October 13, 2017
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P140009
    Removal / Correction Number
    1627487-060217-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) INOPERABLE WHEN EXPOSED TO MONOPOLAR ELECTROSURGERY ADVISORY NOTICE ISSUED BY ABBOTT ON (B)(6) 2017. THE CONCOMITANT DEVICE(S) IS UNKNOWN AT THIS TIME. 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 PATIENT FELL ON (B)(6) 2017 DUE TO AN UNRELATED SUBDURAL HEMATOMA. THE PHYSICIAN DID NOT BELIEVE THE FALL WAS RELATED TO THE IPG. THE PATIENT AND COMPANY REPRESENTATIVE WERE UNABLE TO COMMUNICATE WITH THE IPG FOLLOWING THE SURGERY THAT OCCURRED TO ADDRESS THE HEMATOMA. MULTIPLE TROUBLESHOOTING STEPS WERE ATTEMPTED TO NO AVAIL. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    FOLLOW-UP IDENTIFIED THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT AND REPLACE THE IPG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661742 INFINITY IPG DBS IPG MHY ST. JUDE MEDICAL - NEUROMODULATION 6662 5953106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other