BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 5 ELITE

    MDR report key: 7683629 · Received July 12, 2018

    Report

    Report Number
    1627487-2018-06466
    Event Type
    Injury
    Date Received
    July 12, 2018
    Date of Event
    June 15, 2018
    Report Date
    July 12, 2018
    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
    TX, 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. THE MANUFACTURER 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. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIAGNOSTICS INDICATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED EARLIER THAN INTENDED. THE DEVICE HAD THE APPROPRIATE LEVEL OF BATTERY VOLTAGE TO PROVIDE THERAPY. THE DEVICE WAS EXPLANTED AND REPLACED. (REFERENCE MFR. REPORT#162487-2017-08523 RELATED ISSUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524720 PROCLAIM 5 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3660 5438429 05415067020192

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other