BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA 3MM LEAD, 60 CM

    MDR report key: 5260508 · Received December 2, 2015

    Report

    Report Number
    1627487-2015-09045
    Event Type
    Injury
    Date Received
    December 2, 2015
    Date of Event
    April 22, 2015
    Report Date
    November 17, 2015
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED A LOSS OF THERAPY RESULTING FROM A PREVIOUS FALL IN THE SHOWER. TROUBLESHOOTING REVEALED AN AUTO-REDUCTION IN PROGRAMS. REPORTEDLY, REPROGRAMMING RECAPTURED COMFORTABLE STIMULATION. HOWEVER, HIGH IMPEDANCE WAS NOTED ON MULTIPLE LEAD CONTACTS. FOLLOW-UP IDENTIFIED SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2015 DURING WHICH TIME THE CERVICAL LEAD WAS EXPLANTED AND REPLACED WITH A NEW MODEL PLACED AT THE SAME POSITION. FURTHERMORE, THE PHYSICIAN DISCOVERED THE PREVIOUS LEAD WAS FRACTURED. THE IPG WAS ELECTIVELY REPLACED WITH AN UPDATED MODEL DURING THE SAME PROCEDURE. THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790735 PENTA 3MM LEAD, 60 CM SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3228 4424584

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other MODEL 3788, SCS IPG