BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3240647 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12085
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 27, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3058, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3093-33, LOT # V813526, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED NO ANOMALY. A KNOWN GOOD LEAD WAS ABLE TO BE COMPLETELY INSERTED INTO THE CONNECTOR PORT WITHOUT DIFFICULTY. THE CONNECTOR PORT WAS CHECKED WITH A FIBER OPTIC SCOPE AND NO ANOMALIES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) REMOVED THE IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO DIFFICULTY INSERTING THE LEAD INTO THE INS HEADER BLOCK. THE REPORTER STATED SURGERY WAS DONE ON (B)(6) 2013 AND THE HCP ANTICIPATED DOING A LEAD REVISION, BUT AFTER STARTING THE SURGERY THE HCP NOTICED THE INS WAS DEFECTIVE. IT WAS NOTED THE HCP COULD NOT INSERT THE LEAD INTO THE HEADER BLOCK. IT WAS FURTHER NOTED THE SET SCREW CLICKED USING THE TORQUE WRENCH, BUT THE SCREW WAS NOT TIGHTENING DOWN ON THE LEAD SO THE INS WAS REPLACED. ADDITIONAL INFORMATION RECEIVED REPORTED THE INS WAS NOT ¿LOCKING IN, THERE WAS NO CLICK FROM THE TORQUE WRENCH¿ SO THE LEAD WAS NOT TIGHTENED DOWN. IT WAS NOTED ANOTHER INS WAS USED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE SMALL SCREW AND LOCKING MECHANISM ON THE INS WOULD NOT ENGAGE PROPERLY AND THE LEAD KEPT PULLING OUT OF THE INS. IT WAS NOTED A ¿CLICK¿ WAS HEARD WHEN THE SCREW DRIVER WAS USED, BUT THE LEAD WAS NOT LOCKED INTO THE INS. THE REPORTER STATED THE INS WAS NOT WORKING. IT WAS NOTED THE EVENT OCCURRED DURING THE REVISION OF THE LEAD. IT WAS FURTHER NOTED THAT THERE WAS NO PATIENT INJURY AND THE PATIENT STATUS AFTER THE INS WAS REMOVED WAS RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341325 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention