BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3200239 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11143
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    September 17, 2012
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3889-28, LOT# V467820, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT COULD NOT FEEL STIMULATION UNLESS THEY WERE CHANGING POSITIONS. THIS WAS STATED TO HAVE STARTED ABOUT 2-3 MONTHS PRIOR TO REPORT. ABOUT TWO MONTHS LATER, AND AS OF THE DATE OF THIS REPORT, IT WAS INDICATED THE CAUSE OF THE EVENT WAS UNKNOWN. BOTH LEADS HAD IMPEDANCE MEASUREMENTS OF GREATER THAN 4,000 OHMS. AN EXPLANT WAS NOTED, BUT THE DATE HAD YET TO BE DETERMINED. A LOSS OF STIMULATION WAS ALSO REPORTED. NO HOSPITALIZATION WAS REPORTED AND THE PATIENT OUTCOME WAS NO INJURY. INFORMATION RECEIVED TWO DAYS LATER INDICATED THERE WERE ¿OPEN¿ IMPEDANCES ON ALL ELECTRODES. IT WAS FURTHER STATED THE SYSTEM NEEDED TO BE REPLACED. ABOUT NINE MONTHS LATER, IT WAS STATED THE PATIENT MET WITH THEIR DOCTOR AND MANUFACTURER REPRESENTATIVE IN (B)(6) 2012. IT WAS INDICATED THAT ¿SOMETHING WAS DAMAGED,¿ BUT IT WAS TO BE REPAIRED. IT WAS UNCLEAR WHAT THIS WAS IN REFERENCE TO. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2012, BUT AFTER HAVING A PHYSICAL, IT WAS NOT CERTAIN THAT THE PATIENT¿S HEART BEAT WAS ¿GOOD¿ AND THEY WANTED A SECOND OPINION. AN ELECTROCARDIOGRAM AND STRESS TEST WERE CONDUCTED AND IT CAME OUT ¿GOOD.¿ THE PATIENT THEN FELL IN (B)(6) 2013 SO THE SURGERY COULD NOT BE DONE AROUND THAT TIME. IT WAS NOTED THE PATIENT WAS SCHEDULED TO HAVE SURGERY ON (B)(6) 2013. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED. REFER TO MANUFACTURER REPORT # 3004209178-2012-09186. THE PATIENT HAD TWO DEVICES AND IT WAS UNCLEAR IF THE EVENT PERTAINED TO ONE OR BOTH DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299292 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention