BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3080332 · Received April 26, 2013

    Report

    Report Number
    3004209178-2013-06959
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 11, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-56, LOT# V821427, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3888-56, LOT# V821427, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEAD HAD MIGRATED. IT WAS FURTHER NOTED THAT THERE WAS A "PALPABLE LUMP" IN THE PATIENT'S NECK. IT WAS NOTED THAT THE PATIENT EXPERIENCED A LACK OF COVERAGE IN THE AREA OF PAIN. IT WAS NOTED THAT THE PATIENT HAD TWO REVISIONS ON (B)(6) 2012. IT WAS FURTHER NOTED THAT THE PATIENT HAD BEEN REDUCING HIS MEDICATION AND WAS FEELING BETTER. IT WAS FURTHER REPORTED THAT THE PATIENT HAD GREAT COVERAGE ALMOST 12 MONTHS AFTER HIS ORIGINAL PERMANENT PLACEMENT..

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD PINCHING PAIN IN THE NECK. IT WAS NOTED THAT THE PATIENT HAD A TWISTS IN THE NECK AND FELT A PINCH AND IT FELT THAT VOLTAGE WAS SHOOTING TO THAT AREA AND IT BECAME UNCOMFORTABLE "VAS 2/10." IT WAS NOTED THAT THERE WERE CHANGES IN THE PATIENT'S CONDITION. IT WAS NOTED THAT THE PATIENT STATED THAT HE HAD PINCHING PAIN OCCASIONALLY IN THE PATIENT'S NECK WHERE THE LEAD FOR THE STIMULATION WAS. IT WAS NOTED THAT THE SEVERITY OF THE EVENT WAS MILD. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE ELECTRODE LEAD. IT WAS NOTED THAT THERE WAS A REVISION DONE TO REPOSITION THE LEAD ON (B)(6) 2012. IT WAS NOTED THAT THE PATIENT HAD A PALPABLE LUMP IN THE NECK. IT WAS NOTED THAT THE PATIENT COMPLAINED OF A PALPABLE LUMP IN THE NECK AND THE PATIENT HAD PERMANENT LEADS IMPLANTED ON THE RIGHT SIDE OF THE NECK. IT WAS NOTED THAT A CERVICAL X-RAY WAS ORDERED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED FOLLOWING THE IMPLANT AND THE APPLICATION OF STIMULATION THE PATIENT INDICATED PAIN IN THE POSTERIOR RIGHT LOWER NECK AT THE SHOULDER. IT WAS NOTED THAT THE PATIENT INDICATED THAT HE HAD A SMALL AREA OF PAIN IN THE LOWER RIGHT SIDE OF HIS NECK AND WAS ALMOST PAIN FREE FOLLOWING THE CROSSOVER PERIOD AT WHICH TIME THE STIMULATION WAS SET TO ITS OPTIMALCONFIGURATION. IT WAS NOTED THAT FOLLOWING THE PERMANENT IMPLANT THE PATIENT DEVELOPED A PINCHING IN HIS NECK WITH OCCASIONAL SHOOTING PAIN. IT WAS NOTED THAT A SMALL LUMP WAS NOTED IN HIS NECK AT THE LOCATION OF THE PINCHING PAIN. IT WAS NOTED THAT THE CAUSE OF THIS WAS THE MIGRATION OF AN IMPLANTED LEAD. IT WAS NOTED THAT ON (B)(6) THE PATIENT HAD A REVISION PROCEDURE WHERE THE LEAD WAS REPOSITIONED. IT WAS NOTED THAT FOLLOWING THE REVISION THE PATIENT REPORTED GOOD RELIEF OF PAIN WITH STIMULATION AND NO FURTHER ISSUES WITH A PINCHING FEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183147 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 00052 YR Required Intervention