BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3833612 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-09654
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: NO SIGNIFICANT ANOMALIES FOUND. IT WAS NOTED THE SETSCREW WAS BACKED OUT TOO FAR. FINAL DEVICE ANALYSIS OF THE LEAD REVEALED THE FOLLOWING: THE INSULATION WAS SEPARATED AT THE BUTT JOINT ON THE DISTAL SIDE OF THE #0 CONNECTOR. ALSO CIRCUIT #3 WAS AN OPEN CIRCUIT AND THERE WAS A SHORT CIRCUIT BETWEEN THE #0 AND #2 CONTACTS.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3889-28, LOT# VA0H0K4, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# VA0H0K4, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WOULD NOT ADVANCE INTO THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR THE STAGE 2 IMPLANT THE DAY OF REPORT. IT WAS STATED THEY INS WAS CHANGED OUT AND THEY STILL COULDN¿T GET THE LEAD TO ADVANCE COMPLETELY. IT WAS NOTED THE SHEATH THAT COVERED THE LEAD WAS PULLED AWAY FROM THE ELECTRODE WIRING AND THE WIRING WAS EXPOSED. REPORTEDLY, THE HEALTHCARE PROVIDER WAS GOING TO IMPLANT A NEW LEAD AND THE PATIENT¿S OUTCOME AT THE TIME WAS UNKNOWN. IT WAS LATER REPORTED THE LEAD HAD BEEN IMPLANTED ON (B)(6) 2014 AND IT WAS EXPLANTED ON (B)(6) 2014. IT WAS STATED THE LEAD WOULD NOT ADVANCE INTO THE BATTERY HEAD AND THE LEAD SHEATH PULLED AWAY. IT WAS NOTED THE REASON FOR REMOVAL WAS DUE TO BREAKAGE OF THE LEAD. REPORTEDLY, THE DEVICE WAS NOT USED IN THE PATIENT AND THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION STATED THE PATIENT WAS IMPLANTED WITH A NEW LEAD AND THEIR OUTCOME WAS SUCCESSFUL. IT WAS REPORTED THE PATIENT WAS DOING WELL WITH SATISFACTORY EFFICACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310009 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR