BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFY

    MDR report key: 3142464 · Received June 3, 2013

    Report

    Report Number
    3007566237-2013-01830
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3537, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3537, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3531, SERIAL# (B)(4). PRODUCT TYPE: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 309101, SERIAL # UNKNOWN, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 309101, SERIAL # UNKNOWN, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 367637, PRODUCT TYPE PRODUCT ID 367637; PRODUCT TYPE. 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

    ANALYSIS OF THE TWO CABLES, PRODUCT (B)(4), FOUND NO ANOMALIES.

    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 THERE WAS AN ISSUE WITH THE BILATERAL TRIAL PATIENT¿S LEADS, CONTROLLERS, AND STIMULATORS. ON BOTH SIDES THE CONTROLLER DID NOT ALLOW INCREASING THE AMPLITUDE BEYOND VALUES BETWEEN 4 AND 4.8 MILLIAMPERES. A WARNING MESSAGE DISPLAYED ¿SETTINGS NOT AVAILABLE.¿ THE STIMULATORS AND CONTROLLERS WERE SWAPPED, WHICH LED TO NO CHANGE. THEN BOTH LEADS WERE CONNECTED WITH ONE ¿N O-GROUNDPAD¿ CABLE AND UNILATERAL STIMULATION WAS PERFORMED. THIS WORKED UNTIL THE PATIENT REPORTED A ¿STRONG SENSATION¿ AT ABOUT 6.8 MILLIAMPERES. WHEN TRYING TO CONNECT TO NEW CABLES, BOTH LEAD CONNECTORS BROKE. THE PATIENT SHOWED ONLY A WEAK MOTOR RESPONSE IN THE OPERATING ROOM (OR) AT FULL OUTPUT, SO IT WAS ¿GUESSED¿ THE IMPEDANCES ¿MIGHT NOT BE NORMAL.¿ THE LEADS WERE SCHEDULED TO BE REPLACED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURING REPORT #300756623 7-2013-01829 FOR THE OTHER STIMULATOR IN THIS BILATERAL TRIAL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ¿THREE DAYS LATER, IT STARTED THE TWO STAGE TEST WITH TINED LEAD.¿ A RETURN OF THE BROKE LEADS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE ¿PATIENT WAS AFTER THE 2-STAGE TEST IMPLANTED THE TWIN. NOW THE PATIENT WAS LUCKY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244135 VERIFY STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention