BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 8130174 · Received December 4, 2018

    Report

    Report Number
    1627487-2018-12584
    Event Type
    Injury
    Date Received
    December 4, 2018
    Date of Event
    November 12, 2018
    Report Date
    January 30, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020192
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487/09/12/2017/001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE NEUROMODULATION IMPLANTABLE PULSE GENERATOR (IPG) INACCURATE ELECTIVE REPLACEMENT INDICATOR ADVISORY NOTICE ISSUED BY ABBOTT ON 12 SEPTEMBER 2017. CORRECTIONS: UPDATED FOR CLARIFICATION. ADDED MODEL 3660; SCS IPG. ADDED PMA/520(K): P010032. (B)(4). ADDED ADVISORY NOTICE STATEMENT.

    Description of Event or Problem · 1

    REVIEW REVEALED SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS REPLACED. THERAPY WAS RESTORED POSTOPERATIVELY.

    Description of Event or Problem · 1

    IT IS REPORTED THE PATIENT WILL UNDERGO SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THEIR ORIGINAL IPG WILL BE REPLACED DUE TO THE DEVICE BEING INOPERABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S IPG HAS REACHED THE END OF BATTERY LIFE AND WAS CONFIRMED INOPERABLE. IN TURN, SURGICAL INTERVENTION IS PENDING AS THE NEXT COURSE OF ACTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970275 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3660 5513486 05415067020192

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4)