BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4080303 · Received September 11, 2014

    Report

    Report Number
    3004209178-2014-16771
    Event Type
    Injury
    Date Received
    September 11, 2014
    Report Date
    August 14, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V896806, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR, SERIAL #(B)(4), FOUND THE BATTERY AT NORMAL END OF LIFE WITH NO TELEMETRY OR OUTPUT. THERE WAS NO SIGNIFICANT ANOMALY. THERE WERE NO VISUAL OR ELECTRICAL ANOMALIES WITH THE HYBRID CIRCUIT. DESTRUCTIVE ANALYSIS OF THE BATTERY DID NOT FIND ANY INTERNAL ANOMALIES THAT WOULD HAVE CAUSED PREMATURE BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SCHEDULED AN APPOINTMENT ON THE DAY OF THE REPORT BECAUSE HER SYMPTOMS HAD GOTTEN WORSE AND HER PROGRAMMER DID NOT WORK (PATIENT THOUGHT IT WAS BROKEN); WHICH BEGAN TWO WEEKS PRIOR. AT THE APPOINTMENT, IT WAS DETERMINED THAT THE PROGRAMMER WAS JUST OUT OF BATTERIES. ALSO, NEITHER THE PATIENT OR CLINICIAN PROGRAMMERS COULD READ THE IMPLANTABLE NEUROSTIMULATOR (INS). ANOTHER CLINICIAN PROGRAMMER WAS USED FOR CONFIRMATION WITH THE SAME RESULT. THE TELEMETRY ISSUES ALSO BEGAN TWO WEEKS PRIOR WHEN THE PATIENT TRIED TO CHECK THE INS. NO ERROR MESSAGES WERE SEEN. TECHNICAL SUPPORT WAS THEN CALLED AND IT WAS THOUGHT THAT THE BATTERY WAS DRAINED. IT WAS STATED THAT STIMULATION WAS UP TO 8.5 VOLTS AND THE PATIENT NEVER TRIED OTHER PROGRAMS. THE INS WAS REPLACED ON (B)(6) 2014 AND STIMULATION WAS AT 2.8 VOLTS ON PROGRAM 3 (-2,+0). IT WAS THOUGHT THAT THE BATTERY DRAINED DUE TO THE HIGH AMPLITUDE. THE HEALTHCARE PROVIDER (HCP) WAS UNSURE IF THIS WAS NORMAL, AS HE THOUGHT IT WAS QUICK. THERE WAS NO INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561228 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Required Intervention