BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM 7 ELITE

    MDR report key: 7873209 · Received September 13, 2018

    Report

    Report Number
    1627487-2018-08704
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 17, 2018
    Report Date
    December 23, 2024
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    05415067020222
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-06/07/24-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FSCA NUMBER IS PENDING.

    Additional Manufacturer Narrative · 0

    THE FSCA NUMBER IS INCLUDED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    INSUFFICIENT TIME BETWEEN ELECTIVE REPLACEMENT INDICATOR MESSAGE AND END OF SERVICE WAS REPORTED TO ABBOTT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THIS COMPLAINT WAS IDENTIFIED IN HHE 2024-015 COMPLAINT REVIEW FOR LATE ERI NOTIFICATION FOR ORION IPGS. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INSUFFICIENT TIME BETWEEN ELECTIVE REPLACEMENT INDICATOR MESSAGE AND END OF SERVICE WAS REPORTED TO ABBOTT. THE DEVICE WAS DISCARDED BY THE HOSPITAL AND NOT RETURNED FOR ANALYSIS. THIS COMPLAINT WAS IDENTIFIED IN CAPA 137104 COMPLAINT REVIEW FOR LATE ERI NOTIFICATION FOR ORION IPGS. AS A RESULT OF THIS FINDING, ABBOTT IS PERFORMING FURTHER INVESTIGATION. THE IPG DID NOT MEET THE CALCULATED NUMBER OF EXPECTED DAYS BETWEEN THE OCCURRENCE OF ERI AND THE OCCURRENCE OF EOS.

    Description of Event or Problem · 0

    UPON RETROSPECTIVE REVIEW, THE PATIENT LOST THERAPY DUE TO DEVICE REACHING END OF SERVICE (EOS) FROM ELECTIVE REPLACEMENT INDICATOR (ERI) SOONER THAN EXPECTED AND REPLACEMENT SURGERY WAS REQUIRED TO RESTORE THERAPY.

    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 12SEPTEMBER2017. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION FSCA NOT APPLICABLE AS PREVIOUSLY REPORTED. FURTHER REVIEW OF THE COMPLAINT IDENTIFIED THE PATIENT'S SCS IPG BATTERY WAS PREMATURELY DEPLETING.

    Additional Manufacturer Narrative · 1

    REPORT TYPE CHANGED TO "SERIOUS INJURY". THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIAGNOSTICS INDICATED THE ELECTIVE REPLACEMENT INDICATOR (ERI) TRIGGERED EARLIER THAN INTENDED. THE DEVICE HAS THE APPROPRIATE LEVEL OF BATTERY VOLTAGE TO PROVIDE THERAPY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG HAD DEPLETED AND DID NOT HAVE ENOUGH VOLTAGE TO DELIVER EFFECTIVE THERAPY. IN TURN, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT AND REPLACE THE IPG. THERAPY WAS RESTORED POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714238 PROCLAIM 7 ELITE SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3662 5606728 05415067020222

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female MODEL 3186, SCS LEAD