BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4802555 · Received May 28, 2015

    Report

    Report Number
    3004209178-2015-09842
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 3, 2015
    Report Date
    May 4, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V192503, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS NO TELEMETRY AND THE PATIENT WAS NOT ABLE TO MAKE AN ADJUSTMENT BOTH WITH AND WITHOUT THE ANTENNA ATTACHED. STIMULATION WAS FELT, BUT THE PATIENT COULD NOT ADJUST BETWEEN PROGRAMS. THE PATIENT WAS ¿TOTALLY¿ INCONTINENT ON HER CURRENT PROGRAM, BUT WAS ABLE TO SWITCH TO ANOTHER PROGRAM WITH HER ¿BROKEN¿ PROGRAMMER. A COUPLE DAYS LATER, PATIENT STILL HAD THE SAME ISSUES OF INCONTINENCE AND NOT HAVING HER PROGRAMS LOADED. ADDITIONALLY, THE PATIENT WAS ¿GETTING UNCOMFORTABLE¿ NOT HAVING THE PROGRAMS AVAILABLE. ON (B)(6) 2015, THE PATIENT¿S OLD PROGRAMMER ¿FAILED¿ AND THE NEW ONE ONLY HAD ONE PROGRAM, NOTING THE PATIENT NEEDED 4 TO ¿FUNCTION.¿ STIMULATION WAS NOTICEABLY ¿WEAKER¿ DURING THE NIGHT SO SHE HAD TO CHANGE PROGRAMS MORE FREQUENTLY. THE PATIENT REPORTEDLY SAW THEIR HEALTHCARE PROVIDER (HCP) FOR REPROGRAMMING, AND THEN SCHEDULED AN APPOINTMENT WITH THE MANUFACTURE REPRESENTATIVE. THE MANUFACTURE REPRESENTATIVE AND THE HCP STATED THAT IT ¿MAY BE HER INTERNAL DEVICE FAILED.¿ THE PATIENT STATED THAT ¿SHE HAD NOT BEEN FUNCTIONAL PROPERLY¿ SINCE (B)(6) 2015, CONFIRMING THAT SHE LOST CONTROL OF SYMPTOMS ON THAT DATE AND COULD NOT PROGRAM. SYMPTOMS AND INCONTINENCE ¿HAD GOTTEN VERY BAD THE LAST WEEK OR SO.¿ THE PATIENT WAS TO SEND PROGRAMMER IN FOR REPAIR ON (B)(6) 2015. FOLLOW-UP IS BEING CONDUCTED TO DETERMINE CAUSE, ACTION, AND OUTCOME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR A MANUFACTURER REPRESENTATIVE. THE PATIENT WAS AWAITING AN APPOINTMENT DATE TO HAVE THEIR DEVICE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346744 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention "SEE H10...."