BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 15672920 · Received October 26, 2022

    Report

    Report Number
    3006705815-2022-17594
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    September 30, 2022
    Report Date
    November 29, 2022
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)
    Product Code
    LGW
    UDI-DI
    05415067031419
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE IS ESTIMATED.

    Additional Manufacturer Narrative · 0

    THE REPORTED OBSERVATION OF ¿CANNOT CONNECT TO GENERATOR¿ WAS CONFIRMED. THE INABILITY TO ESTABLISH COMMUNICATION WITH THE DEVICE WAS DUE TO IT HAVING REACH ITS END OF LIFE. THE ROOT CAUSE OF THE REPORTED OBSERVATION WAS NOT ASCERTAINED. THE IPG DIAGNOSTIC LOGS DID CONFIRM THE DEVICE EXHIBITED A CHANGE IN PERFORMANCE AFTER 6/28/2022. IT WAS NOTED THAT AN ATTEMPT TO PLACE THE DEVICE IN MRI MODE OCCURRED ON 6/17/2022; THIS WAS CAPTURED IN THE EVENT DETAILS IN THE ASSOCIATED PER-2022-0093991. NO FURTHER INFORMATION WAS PROVIDED FROM THE FIELD CONCERNING IF THE PATIENT HAD AN MRI ON 6/17/2022. THE ESTIMATED LONGEVITY WOULD HAVE BEEN 5.5 YEARS +/- .25-YEAR PER ¿ 90205144, ASSUMING 1000-OHM PROGRAM IMPEDANCES, FOR MODEL 3660. USING THE PATIENT¿S LAST KNOWN SETTINGS. THE TOTAL STIMULATION ON TIME WAS 550 DAYS OR 1.5 YEARS. THE DEVICE DID NOT MEET IT ESTIMATED LONGEVITY BASED ON THE PROGRAMMING HISTORY. THE DEVICE WAS SUBJECTED TO A FUNCTIONAL TEST ON AUTOMATED TEST EQUIPMENT (ATE). THIS TESTER VERIFIES THE ELECTRICAL PERFORMANCE OF THE CONTROL/COMMUNICATION CIRCUITRY, AND OUTPUT SIGNAL INTEGRITY. ALL PORTIONS OF ATE TESTING PASSED. THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTIC DURING ANALYSIS. THE RETURNED IPG FAILED THE PROCLAIMXR BATTERY WARRANTY EVALUATION AS THE PROGRAMMING REQUIREMENTS WERE NOT FOLLOWED. THE IPG PROGRAMMING USED CONTINUOUS MODE AND EXCEEDED THE AMPLITUDE LIMITS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG DEEMED INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2599372 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) 3660 A000099287 05415067031419

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other SCS LEAD (X2).