BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 3955194 · Received July 24, 2014

    Report

    Report Number
    6000032-2014-00151
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3887-33, LOT# J0123294V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID: 7434A, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708320, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 389033, LOT# J0406225V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED A MANUFACTURING REPRESENTATIVE WAS GOING TO ATTEND A BATTERY REPLACEMENT PROCEDURE. THE BATTERY WAS REPORTED TO BE AT END OF SERVICE (EOS). IT WAS STATED THAT THE PROCEDURE MAY INVOLVE REPLACING A CERVICAL LEAD AS WELL. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS RECEIVING AN UNPLEASANT-SHARP PARESTHESIA SENSATION. A REVISION OF THE SPINAL CORD SYSTEM WAS DONE ON (B)(4)2014. DURING THE REVISION SURGERY, IT WAS FOUND THAT 1 LEAD AND 1 EXTENSION WERE NOT WORKING PROPERLY. THE EXTENSION WAS NOT GIVING DESIRED IMPEDANCES AND WAS REPLACED. A LEAD WAS ALSO REPLACED DUE TO AN IMPROPER IMPEDANCE CHECK. IT WAS NOTED THAT THE REPLACED EXTENSION AND LEAD WERE NOT CONNECTED TOGETHER, BUT RATHER 2 INDEPENDENT PROBLEMS. THE PATIENT WAS EXPERIENCING PAIN DUE TO NOT HAVING THE SPINAL STIMULATOR OFF. WHEN THE STIMULATOR WAS ON, THE PATIENT EXPERIENCED UNDESIRABLE STIMULATION WHICH WAS A CAUSING SHARP PARESTHESIA SENSATION. THE BATTERY STILL HELD A GOOD CHARGE, BUT IT WAS REPLACED ANYWAYS SINCE THE LEADS WERE BEING REVISED. THE PATIENT WAS IN CONTINUOUS MODE. IT WAS NOTED THAT THE PATIENT WAS HAPPY AND RECEIVING PROPER THERAPY FROM THE SPINAL CORD STIMULATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ¿(B)(6)¿ OR ¿PAST WEEKEND¿ THE PATIENT FELT THE STIMULATOR ¿JUMP.¿ PATIENT SERVICES ASKED THE CALLER WHAT THIS MEANT AND THE PATIENT REPLIED IT WAS CHARGED, BUT ¿NOT FEELING RIGHT.¿ THE PATIENT NOTED SHE WAS ¿FEELING THE BOTTOM, BUT NOT THE TOP.¿ THE PATIENT STATED SHE COULD FEEL STIMULATION IN THE LEGS, BUT ¿DID NOT FEEL HER ARMS.¿ THE PATIENT STATED SHE HAD TO TURN IT ALL THE WAY UP TO 6.00, BUT THEN SHE STARTED TO TWITCH. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). THE PATIENT STATED THERE WERE NO FALLS. THE PATIENT ALSO STATED SHE HAD AN APPOINTMENT AT THE DOCTOR ON ¿(B)(6).¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT # 3004209178-2014-13480.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434236 ITREL 3 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7425

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR