BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 19196691 · Received April 26, 2024

    Report

    Report Number
    1627487-2024-08390
    Event Type
    Malfunction
    Date Received
    April 26, 2024
    Date of Event
    March 18, 2024
    Report Date
    April 26, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. MEDWATCH REPORT MW5153012 RECEIVED TO NMD COMPLAINTS ON (B)(6) 2024: CALLER REPORTS INS BATTERY IS DEAD AND UNABLE TO RECHARGE. CALLER THEN STATED DEVICE IS A PROCLAIM XR7 TECHNICAL SERVICES REDIRECTED TO ABBOTT. PATIENT OPTED TO NOT PROVIDE CONTACT INFORMATION. FURTHER INFORMATION CANNOT BE OBTAINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MEDWATCH FORM (MW5153012) THAT THE PATIENT'S SCS IPG WAS INOPERABLE. INITIAL REPORTER ELECTED NOT TO BE IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122645 PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ABBOTT MEDICAL 3662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown