BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3011566 · Received March 19, 2013

    Report

    Report Number
    3004209178-2013-03941
    Event Type
    Injury
    Date Received
    March 19, 2013
    Report Date
    July 8, 2016
    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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S BATTERY WAS SUCCESSFULLY CLEARED FROM A POWER ON RESET. AFTER THIS CLEARING, THE PATIENT WAS SUCCESSFULLY GETTING STIMULATION, HOWEVER, IT WAS REPORTEDLY AN "UNCOMFORTABLE STIMULATION." IT WAS ALSO NOTED THAT WHEN THE LEFT LEAD WAS PROGRAMMED, THE PATIENT'S LEFT SIDE OF HER BODY WAS STIMULATED. HOWEVER, WHEN THE RIGHT LEAD WAS PROGRAMMED, AGAIN THE LEFT SIDE OF THE BODY WAS STIMULATED. IT WAS REPORTED THE PHYSICIAN BELIEVED THERE WAS A "BAD TAIL LEAD." THE PHYSICIAN PLANNED TO DO A REVISION TO FIX THE LEAD. THE DATE OF THE REVISION WAS UNKNOWN AT TIME OF THIS REPORT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROVIDER CONFIRMED THAT THE CAUSE OF THE EVENT WAS LEAD MOVEMENT. THE PATIENT UNDERWENT A SURGICAL REVISION AND RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THAT THEY WENT IN FOR A SURGERY AND THE ORTHOPEDIC SURGEON HAD TO CAGE AND FUSE MORE OF THEIR BACK THEN WAS EXPECTED. AS A RESULT THE PADDLE LEADS HAD TO BE PLACED HIGHER THAN THEY ORIGINALLY WERE SO BECAUSE OF THE NEW PLACEMENT OF THEIR LEADS, THE STIM DID NOT COVER THE LOW/MID BACK AND DOWN THE LEGS LIKE IT WAS SUPPOSED TO IN ORDER TO COVER THEIR INJURY. THE STIM HITS/HURTS THE RIBS AND UPPER BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113736 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 39 YR Required Intervention