BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50CM IMPLANT LEAD KIT, SLIM TIP

    MDR report key: 8147596 · Received December 10, 2018

    Report

    Report Number
    1627487-2018-12672
    Event Type
    Injury
    Date Received
    December 10, 2018
    Date of Event
    August 20, 2018
    Report Date
    January 8, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE ASSOCIATED MDRS MDR-2018-50969, MDR-2018-50963.

    Additional Manufacturer Narrative · 1

    UPDATED EVENT DESCRIPTION TO REFERENCE CORRECT RELATED MDR REPORT NUMBERS AND TO CORRECT SYSTEM TYPE REFERENCED. ADDED MODEL MN10450-50A; DRG LEAD. PMA CODE: ADDED P150004. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THEIR SCS SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON.

    Description of Event or Problem · 1

    DEVICE 3 OF 3. REFERENCE MFR. REPORT#1627487-2018-12665. REFERENCE MFR. REPORT#1627487-2018-12669. IT WAS REPORTED THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2018 WHERE THEIR DRG SYSTEM WAS EXPLANTED FOR AN UNKNOWN REASON AND THE LEADS WERE CUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987234 50CM IMPLANT LEAD KIT, SLIM TIP DRG LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-50A 6225103 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other MN10450-50A