BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3150722 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08749
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE STIMULATOR REVEALED NO SIGNIFICANT ANOMALIES. THE STIMULATOR WAS FUNCTIONALLY OKAY. A HEAT TEST WAS PERFORMED TO ADDRESS THE COMPLAINT OF OVER-HEATING WHILE RECHARGING; THE COMPLAINT WAS UNABLE TO BE DUPLICATED IN THE LAB, THERE WERE NO ANOMALIES FOUND.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3487A-56, LOT# V195020, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT# V195020, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT# V195020, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT# V195020, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT# V083355, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD COMPLAINED OF SHORT RECHARGE INTERVAL AND UNCOMFORTABLE IMPLANTABLE NEUROSTIMULATOR (INS) HEATING DURING CHARGING SESSIONS. THE PATIENT¿S INS WAS EXPLANTED AND REPLACED. IMPEDANCE TESTING AND REPROGRAMMING WERE PERFORMED AND THE PATIENT¿S RECHARGING UNIT WAS CHECKED AND COUPLING WAS VERIFIED, ALL WERE WORKING FINE. THE PATIENT EXPERIENCED UNCOMFORTABLE RECHARGING AT HER DEVICE POCKET. THE PATIENT RESOLVED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE HAD MOVED 2 INCHES TO THE LEFT AND 2 INCHES UP, AND HAD BECOME UNSTITCHED AND 'UN-ENCAPSULATED'. IT WAS NOTED THAT THE PATIENT HAD NO EVENT / TRAUMA THAT WOULD HAVE MOVED THE DEVICE. THE PATIENT HAD NOTICED SOME STINGING / DISCOMFORT 'BACK THERE' FOR AT LEAST A MONTH, BUT DIDN¿T ATTRIBUTE THE DISCOMFORT TO THE DEVICE AND THOUGHT SHE MAY HAVE JUST 'MOVED WRONG'. IT WAS NOTED THAT THE PATIENT WAS LESS THAN 100 POUNDS AND THAT MAY BE A FACTOR. THE DEVICE LODGED ON A BONE AND WAS STATIONARY. THE PATIENT WENT TO THE HCP OFFICE AND STATED THAT MOVEMENT WAS CONFIRMED. THE HCP GAVE THE PATIENT THREE OPTIONS, REMOVAL, ADJUSTMENT, OR REMOVAL OF CURRENT DEVICE AND UPGRADE TO RESTORE SENSOR. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WOULD BE SCHEDULED FOR REPLACEMENT OF THE PULSE GENERATOR ON (B)(6) 2013. IT WAS NOTED THE PATIENT EXPERIENCED AN INCREASE IN PAIN AND TENDERNESS AROUND THE PULSE GENERATOR. IT WAS REPORTED THAT THE PATIENT DID NOT REQUIRE HOSPITALIZATION AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250802 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention