BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2884167 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12192
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    October 6, 2015
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: ADDITIONAL REVIEW INDICATED THE DEVICE HAD NOT YET BEEN RETURNED. THE NOTE ABOUT PENDING ANALYSIS PREVIOUSLY SUBMITTED WAS ADDED IN ERROR.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-33, LOT# V645573, IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE PATIENT¿S PRIOR 2 IMPLANTS WERE REPLACED DUE TO THE LEADS COMING OFF AND THE DEVICE STOPPED WORKING. ALL OF THE UNITS HAD BEEN SENT BACK TO THE MANUFACTURER BY THE MANUFACTURER REPRESENTATIVE. THE INDICATION FOR USE FOR THIS PATIENT WAS OTHER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS REPLACED ON (B)(6) 2013 AND THE PATIENT WAS "EASILY PROGRAMMED" AND FELT THE NEW DEVICE WAS "BETTER." NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT ON ALL OF THE TIME. IT WAS STATED THE PATIENT HAD THE INS ON AT .6V. FOUR DAYS LATER, IT WAS REPORTED THE PATIENT HAD FELL AND THAT WAS THE POINT THE INS STOPPED WORKING. THE INS WAS SET TO BE REPLACED ON (B)(6), 2013. THE LEAD WAS ALSO STATED BE 'POSSIBLY' REPLACED AT THE SAME TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A SECOND FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE CONSUMER NOTED THE STIMULATOR MALFUNCTIONED. THEY FOUND OUT IT WAS NOT WORKING IN (B)(6)-2012. THE DOCTOR WAS JUST AS CONFUSED AS THE PATIENT AS TO WHY THE LEAD WAS DISCONNECTED. THE LEAD BECAME DISCONNECTED FROM THE IMPLANTABLE NEUROSTIMULATOR (INS). THERE WAS NO FALL OR TRAUMA RELATED TO THIS ISSUE. THE PATIENT COULD FEEL THE DEVICE MOVING INSIDE HER AFTER THE DISCONNECTION. IT WAS UNKNOWN WHAT TROUBLE SHOOTING WAS PERFORMED RELATED TO THE SHOCKING SENSATION/ DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE "FAILED" OR "STOPPED WORKING COMPLETELY" SIX MONTHS AFTER IMPLANT. THE DEVICE LASTED LESS THAN A YEAR. IT WAS STATED THAT THEY COULD "NOT GET ANYTHING TO WORK ON IT."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED LATER PATIENT COULD NOT FEEL STIMULATION AT ALL BUT HER BATTERY HAD DEPLETED AND HAD IT REPLACED.

    Description of Event or Problem · 1

    ON (B)(6)-2012, IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR HAD NOT WORKED 3 WEEKS PRIOR TO THE REPORT. ABOUT 2 WEEKS PRIOR, THERE WAS NO RESPONSE FROM THE IMPLANT AT AN APPOINTMENT WITH A HEALTHCARE PROFESSIONAL (HCP) AND A COMPANY REPRESENTATIVE. X-RAY EVALUATION SHOWED THAT THE "WIRES WERE CONNECTED." IT WAS STATED THAT THERE WAS SUPPOSED TO BE A SURGERY SCHEDULED FOR THE DAY OF THE REPORT BUT IT WAS CANCELED "DUE TO INSURANCE." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention