BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 2092388 · Received May 2, 2011

    Report

    Report Number
    3004209178-2011-03195
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN HAD TO CUT OFF THE #3 ELECTRODE FROM THE LEAD DURING SEVERAL IMPLANT PROCEDURES. DURING THE IMPLANT, THE PHYSICIAN WOULD TUNNEL THE LEAD BEHIND THE EAR. THIS WOULD CAUSE THE #3 ELECTRODE TO DISCONNECT FROM THE LEAD BODY. HE THEN WOULD HAVE TO CUT OFF THE #3 ELECTRODE WITH A SURGICAL SCISSORS. THE PHYSICIAN FELT THAT THE LEAD CAP WITH THE 1 SET SCREW DID NOT PROVIDE A SECURE ATTACHMENT. ONE TO TWO WEEKS POST LEAD IMPLANT, DURING THE STAGE II IMPLANT, THE PHYSICIAN IMPLANTED EXTENSIONS AND THE NEUROSTIMULATOR. IT WAS THE COMPANY REPRESENTATIVE'S IMPRESSION THAT DURING THE STAGE II IMPLANT, THE PHYSICIAN PULLED THE LEAD DOWN BY GRASPING THE LEAD CAP, WHICH POTENTIALLY DAMAGED THE CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| UNKNOWN LEAD: MODEL DBSLEAD, LOT# UNKNOWN| EXPLANTED: