BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR

    MDR report key: 15555596 · Received October 6, 2022

    Report

    Report Number
    1627487-2022-05379
    Event Type
    Injury
    Date Received
    October 6, 2022
    Date of Event
    September 9, 2022
    Report Date
    December 23, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067020215
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF THE EVENT IS ESTIMATED. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. THE ALLEGATION IS AGAINST 1 OF 3 LEADS; HOWEVER, IT IS UNKNOWN WHICH COMPONENTS, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS LEAD, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 8081547. COMMON DEVICE NAME: SCS LEAD, MODEL: MN10450-90A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 8176651.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT FOR UNCOMFORTABLE STIMULATION AND HEATING AT THE IPG SITE WAS NOT CONFIRMED. VISUAL INSPECTION OF THE IPG DID NOT IDENTIFY ANY ANOMALIES THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. THE IPG WAS FUNCTIONALLY TESTED AND PASSED ALL TESTING. THE FIELD SCENARIO WAS RECREATED TO ADDRESS THE ISSUE OF HEATING. THE IPG MET THE PRODUCT REQUIREMENT SPECIFICATION FOR HEAT GENERATION DURING USE.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REFERENCE NUMBER 1627487-2022-05378. IT WAS REPORTED THE PATIENT WAS EXPERIENCING UNCOMFORTABLE STIMULATION (ZAPPING) AT THE GROIN AND RIGHT LEG AND A WARM SENSATION AT THE IPG POCKET. AS SUCH, THE PATIENT UNDERWENT SURGICAL INTERVENTION WHERE THE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUES. INVESTIGATION WAS UNABLE TO DETERMINE WHICH OF THE DEVICES ATTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531449 PROCLAIM¿ DRG IMPLANTABLE PULSE GENERATOR DRG IPG PMP ABBOTT MEDICAL 3664 8251313 05415067020215

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other