BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2933361 · Received January 29, 2013

    Report

    Report Number
    6000032-2013-00026
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 14, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3080, LOT# L88575, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 3031, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3080, LOT# L88575, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THERE WAS A BREAK IN THE LEAD COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR SYSTEM. THE CAUSE OF THE EVENT WAS NOTED AS UNKNOWN. THE ENTIRE INS SYSTEM WAS THEN REPLACED. FOLLOWING THE REPLACEMENT PROCEDURE, THE PATIENT OUTCOME WAS REPORTED AS RECOVERED WITHOUT SEQUELAE AND DID HAVE A FOLLOW-UP APPOINTMENT SCHEDULED FOR (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IN THE BACK SEAT OF A CAR AND GOT REAR-ENDED ON (B)(6) 2012. THE PATIENT'S IMPLANT "HAS NOT BEEN WORKING" SINCE THE CAR ACCIDENT. IT WAS STATED THAT THE PATIENT WAS SEEING A MESSAGE ON THE PROGRAMMER INDICATING THAT THE BATTERY WAS LOW OR DEAD. THERE WERE NEW BATTERIES IN THE PROGRAMMER. THE PATIENT HAD A DOCTOR APPOINTMENT SCHEDULED TWO WEEKS FROM THE REPORT DATE. LATER THAT DAY, IT WAS REPORTED THAT THE PATIENT WAS GOING TO MEET WITH HER DOCTOR ON (B)(6) 2013. IT WAS STATED THAT THE PATIENT PLANNED TO LET HER DOCTOR KNOW ABOUT THE ACCIDENT SO THAT DIAGNOSTIC TESTS COULD BE DONE. FURTHER INFORMATION HAD BEEN REQUESTED. IF MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39694 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention