BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3191449 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10938
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT TYPE: LEAD, PRODUCT ID: 3778-45, SERIAL# (B)(4), EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FURTHER FOLLOW UP INFORMATION REPORTED THAT THE LEAD COMPONENT WAS REPLACED YESTERDAY AS IT WAS FOUND TO HAVE IMPEDANCES OF >40,000 OHMS WHEN USING A TRIALING CABLE. THE PATIENT HAD THEIR THERAPY RESTORED TO THEIR RIGHT LOWER EXTREMITY WITH A NEWLY IMPLANTED LEAD. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT¿S REVISION SURGERY WAS 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 INITIALLY REPORTED THE PATIENT BENT OVER THE WRONG WAY ON (B)(6) 2013, AND AS OF 3 DAYS AFTER BENDING THE WRONG WAY THE PATIENT WAS STILL EXPERIENCING PAIN. ADDITIONAL INFORMATION RECEIVED APPROXIMATELY 4 MONTHS LATER REPORTED THE PATIENT REQUESTED REPROGRAMMING AS THE DEVICE WAS ¿NOT WORKING PROPERLY NOW.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM A MANUFACTURER REPRESENTATIVE BUT HIS CONCERNS WERE NOT RESOLVED. IT WAS REPORTED ONE OF THE PATIENT¿S TWO LEADS ¿CAME OUT¿ AND IT WAS ONLY WORKING IN ONE LEG. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2013. ADDITIONAL INFORMATION RECEIVED REPORTED IT WAS UNKNOWN IF THE PATIENT¿S LEAD WAS DISCONNECTED FROM THE STIMULATOR OR HAD MOVED FROM THE INTENDED EPIDURAL SPACE BUT WAS ¿SUSPECTED DUE TO LEAD IMPEDANCES OUT OF RANGE FOR ONE ENTIRE LEAD.¿ IT WAS NOTED THE PATIENT WAS GETTING ¿OKAY¿ COVERAGE WITH THE LEAD THAT WAS NOT OUT OF RANGE BUT IT WAS NOT AS ADEQUATE AS IT ONCE WAS. REPROGRAMMING WAS PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT HAD X-RAYS DONE AND NOTHING CONCLUSIVE WAS FOUND BY THE PHYSICIAN. IT WAS REPORTED THE PATIENT WAS GOING TO BE SCHEDULED FOR A LEAD REVISION IN THE NEAR FUTURE. IT WAS NOTED THE PATIENT CONTINUED TO NOT RECEIVE PAIN RELIEF AND ADEQUATE COVERAGE OF THEIR PAINFUL AREAS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND IMPEDANCE MEASUREMENTS READ GREATER THAN 10,000 OHMS. IT WAS ALSO STATED IMPEDANCES GREATER THAN 20,000 AND 40,000 OHMS WERE READ. IT WAS NOTED THE 0-7 LEAD SHOWED ALL OUT OF RANGE IMPEDANCES READINGS AT 0.7, 1.5 AND 3 VOLTS. IT WAS ALSO NOTED AT 3 VOLTS THE ELECTRODE 7 WAS RANGING FROM 30,000 TO 40,000 OHMS. IT WAS STATED ELECTRODE 8-15 WERE RANGING BETWEEN 600 TO 700 OHMS. REPORTEDLY, AN X-RAY WAS DONE THE WEEK PRIOR TO REPORT AND NO FRACTURE OR DISCONNECT AT THE IMPLANTABLE NEUROSTIMULATOR (INS) OR LEAD WAS SEEN. IT WAS NOTED THE PATIENT'S THE 8-15 LEAD COVERED THEIR LEFT LEG PAIN AND THE 0-7 LEAD COVERED THEIR RIGHT LEG PAIN. IT WAS STATED THE PATIENT WANTED BILATERAL LEG AND FEET COVERAGE FOR THEIR PAIN AND THEY WERE ONLY GETTING LEFT LEG COVERAGE AT THE TIME OF REPORT AND THEIR RIGHT STIMULATION COVERAGE STOPPED WORKING AROUND THE MIDDLE OF (B)(6) 2013. IT WAS ALSO REPORTED THE PATIENT'S LEFT LEG STIMULATION WAS TOO STRONG AND THEIR RIGHT LEG STIMULATION WAS SLIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291303 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention