BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

    MDR report key: 8862291 · Received August 5, 2019

    Report

    Report Number
    1627487-2019-08742
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    July 18, 2019
    Report Date
    October 17, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067020215
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: BRAND NAME WAS INADVERTENTLY OMITTED IN THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE COMMON DEVICE NAME SHOULD HAVE BEEN DRG IPG RATHER THAN DBS IPG. CORRECTION: THE DEVICE PRODUCT CODE (FDA PRODUCT CODE CLASSIFICATION) SHOULD HAVE BEEN PMP RATHER THAN MHY. CORRECTION: THE PMA/510(K) # SHOULD HAVE BEEN P150004 RATHER THAN P140009. (B)(4)..

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S IPG DEPLETED. AS SUCH, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHEREIN THE DEVICE WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL. REPORTEDLY, EFFECTIVE THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656209 PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR DRG IPG PMP ST. JUDE MEDICAL - NEUROMODULATION MN10200 6494008 05415067020215

    Patients

    Seq Age Sex Outcome Treatment
    1 Other