BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 11526103 · Received March 19, 2021

    Report

    Report Number
    1627487-2021-02218
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    February 17, 2021
    Report Date
    June 29, 2021
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067020222
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED SHOCKING SENSATIONS FROM THE SYSTEM. DIAGNOSTICS REVEALED THE PATIENTS EXTENSIONS DISPLAYED HIGH IMPEDANCE. X-RAY IMAGING REVEALED THAT ONE OF THE EXTENSIONS GAD DISLODGED FROM THE IPG. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE PATIENTS EXTENSIONS WERE EXPLANTED AND REPLACED. THERAPY WAS RESTORED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICES WERE NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-02216, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2021-02217. IT WAS REPORTED THE PATIENT EXPERIENCED SHOCKING SENSATIONS FROM THE SYSTEM. DIAGNOSTICS REVEALED THE PATIENTS EXTENSIONS DISPLAYED HIGH IMPEDANCE. X-RAY IMAGING REVEALED THAT ONE OF THE EXTENSIONS GAD DISLODGED FROM THE IPG. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2021 WHEREIN THE PATIENTS EXTENSIONS WERE EXPLANTED AND REPLACED. SURGICAL INTERVENTION ADDRESSED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423232 PROCLAIM 7 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ABBOTT MEDICAL 3662 7124434 05415067020222

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL: 3383, SCS EXTENSION (X2)| MODEL: 3383, SCS EXTENSION (X2)