BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR

    MDR report key: 15424138 · Received September 14, 2022

    Report

    Report Number
    1627487-2022-05051
    Event Type
    Injury
    Date Received
    September 14, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 25, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    LGW
    UDI-DI
    05415067020192
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: SCS OCTRODE PERCUTANEOUS LEAD, MODEL: 3186, UDI: (B)(4), SERIAL: (B)(4), BATCH: 5991567.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 1627487-2022-05050. IT WAS REPORTED THAT THE PATIENT HAS A INOPERABLE IPG AND ONE OF THEIR LEADS HAD MIGRATED. THIS LEAD MIGRATION WAS CONFIRMED VIA X-RAY. THE INVESTIGATION DID NOT DETERMINE WHICH LEAD HAD MIGRATED. SURGICAL INTERVENTION WAS UNDERTAKEN THE IPG AND LEAD WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426792 PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR SCS IPG LGW ABBOTT MEDICAL 3660 6082622 05415067020192

    Patients

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