BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3000425 · Received March 12, 2013

    Report

    Report Number
    3004209178-2013-03612
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Report Date
    February 20, 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
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED HER IMPLANTABLE NEUROSTIMULATOR (INS) 'GETTING CLOSER TO THE SKIN.' THE PATIENT FURTHER REPORTED THAT SHE THOUGHT 'THE INS MAY HAVE BEEN WORKING ITS WAY OUT OF HER THE BODY' AND THAT THE INS LOCATION 'CAUSED EXCESSIVE PUSHING/RUBBING ON THE POCKET.' THE PATIENT ALSO STATED THAT THE INS 'FLIPPED IN THE POCKET AND IS MORE SUPERFICIAL THAN IT WAS AT THE TIME OF SURGERY.' THE PATIENT NOTED THAT SHE FELT 'THE LEADS IN HER BACK' AND SHE ADDED THAT THEY WERE 'POKING OR BUMPING AND CAUSING HER NERVE PAIN.' THE PATIENT ALSO STATED THAT 'IT FELT LIKE A SHOOTING LINE OF PAIN.' IT WAS NOTED THAT 'THE INCISION HAD HEALED, BUT THE IMPLANT SITE WAS BRUISED AND PAINFUL.' THE PATIENT REPORTED TURNING THE DEVICE OFF TWO MONTHS AFTER IMPLANT 'BECAUSE SHE DIDN'T LIKE THE WAY IT FELT.' THE PATIENT'S PHYSICIAN NOTED THAT THE INS WAS DISCHARGED BECAUSE THE "PATIENT STOPPED RECHARGING" AND THAT THE INS WAS "NOT IN AN OVERDISCHARGE STATE." THE PATIENT DID NOTE THAT THE INS 'HELPED WITH HER LEGS BUT NOT WITH HER LOWER BACK.' IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED 'MORE MID-BACK PAIN SINCE IMPLANT.' THE PATIENT FURTHER REPORTED HAVING HAD 'SACRUM PAIN WHERE THEY DRILLED TO PUT THE LEAD.' X-RAY RESULTS INDICATED THAT THE 'LEADS AND INS APPEARED TO BE THE SAME AS AT THE TIME OF IMPLANT.' A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103097 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 00032 YR