BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3935538 · Received July 15, 2014

    Report

    Report Number
    3007566237-2014-01963
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-40, LOT# 0208325032, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3389-40, LOT# 0208325033, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE SYSTEM WAS EXPLANTED AND THE PATIENT WAS NOT CURRENTLY RECEIVING THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH LEADS WERE OBSERVED TO BE OVER 32 MM ABOVE THE TARGET IN THE RACHIDIAN BULB. THE REPORTER STATED THAT DURING SURGERY ON (B)(6) 2014 ALL INSTRUCTIONS WERE FOLLOWED AND ¿THE TARGET AT THE DISTANCE FROM THE S7 NAVIGATION MINUS 60 MM, MICROREGISTERING AND STIMULATION WITH REFERENCE FC7100 AND FC7140LI FOR THE FOR CM LEAD INSERTION.¿ THE REPORTER FURTHER STATED THE REGISTER AND MICROSTIMULATION WAS NOT VERY CLEAR. IT WAS NOTED THAT A DECREASE IN THE PATIENT¿S TREMOR WAS OBSERVED ON THEIR LEFT SIDE. IT WAS FURTHER NOTED THAT DURING THE IMPLANT OF THE SECOND LEAD THE PATIENT SUFFERED A RESPIRATORY ARREST. THE REPORTER STATED THE RESPIRATORY REANIMATION WAS DONE DURING SURGERY. THE REPORTER FURTHER STATED THAT BOTH LEADS WERE MEASURED WITH A RULER IN THE KIT. IT WAS NOTED THE HEALTHCARE PROFESSIONAL (HCP) DECIDED NOT TO CONTINUE TESTING SO THE PATIENT WAS ANESTHETIZED AND THE IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED. IT WAS FURTHER NOTED THAT TWO DAYS AFTER SURGERY A CT SCAN WAS DONE TO CONTROL THE POSITION OF THE LEADS AND THE HCP OBSERVED THAT BOTH LEADS WERE 32 MM ABOVE THE TARGET. THE REPORTER STATED THEY EXPECTED BOTH LEADS TO BE EXPLANTED ON (B)(6) 2014 IN AN EMERGENCY OPERATION. IT WAS NOTED THAT THERE WAS NO PATIENT DEATH. ADDITIONAL INFORMATION RECEIVED REPORTED THAT YESTERDAY THE ELECTRODES WERE REMOVED AND THE PATIENT WAS WELL. THE REPORTER STATED THE ELECTRODES WERE FOUND IN THE PATIENT¿S MEDULLA. THE REPORTER FURTHER STATED THE RESULT OF THE SURGERY WAS AN ERROR OF LEAD PLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412893 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R