BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4113528 · Received September 24, 2014

    Report

    Report Number
    3004209178-2014-17616
    Event Type
    Injury
    Date Received
    September 24, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DISCOMFORT AND CHRONIC THROBBING PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE ON THEIR LEFT SIDE SINCE IMPLANT. THE PATIENT WAS ASKED TO SHUT THEIR DEVICE OFF FOR 3-4 DAYS TO SEE IF THEIR DISCOMFORT WENT AWAY OR LESSENED. THE INS WAS IMPLANTED FOR CHRONIC BACK AND LEG PAIN AND THE PATIENT HARDLY HAD ANY PAIN IN THEIR LEGS, BUT WHERE THE INS WAS IMPLANTED WAS IN CHRONIC PAIN. THE PATIENT'S SYMPTOMS HAD A SUDDEN ONSET AFTER IMPLANT AND THE PAIN NEVER WENT AWAY. THE PATIENT STATED THE PAIN FELT DEEP BECAUSE IT HAD THROBBED. THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) MOVED THE INS HIGHER IN THE SAME POCKET ON (B)(6) 2014. THE HCP HAD PRESCRIBED LANACANE PATCHES, BUT THEY WERE NOT HELPING AND THE PATIENT STILL HAD PAIN AT THE INS SITE. THE PATIENT'S PAIN HAD NOT SPREAD OR INCREASED SINCE IMPLANT AND THE INCISION AREA HURT WHEN TOUCHED. AT THE PATIENT'S POST OPERATION VISIT WITH THEIR HCP THE PAIN HAD NOT CHANGED AND THE HCP TOLD THEM TO "GIVE IT TIME, BUT IF IT DID NOT GO WAY THEY DID NOT KNOW WHAT TO DO." THE PATIENT'S THERAPY WAS WORKING ON THEIR LEGS AND THEY DID NOT WANT THE INS TAKEN OUT. AN X-RAY OR CT SCAN HAD NOT BEEN DONE. THE HCP FELT THE PAIN WAS ON THE SURFACE AS OPPOSED TO DEEP PAIN. THE PATIENT THOUGHT IT WAS PRESSING ON NERVES, BUT THE HCP DID NOT THINK SO. PRIOR TO IMPLANT THE PATIENT HAD LUMBAR SURGERY WITH METAL AND SCREWS PUT IN, THAT EVENTUALLY END UP AGAINST SOME NERVES. THE PATIENT THEN HAD SURGERY FOR SPINAL STENOSIS AND THAT PAIN STOPPED, BUT THEY COULD NOT STAND FOR MORE THAN FIVE MINUTES. THE PATIENT HAD "PRETTY SERIOUS SCAR TISSUE AROUND THE LUMBAR SURGERY." NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR HEALTHCARE PROFESSIONAL OR A MANUFACTURER REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED NOTING THAT THE PATIENT HAD THE INS MOVED FROM THE LEFT LOW BACK BUTTOCK TO HER LEFT ABDOMEN. THE PATIENT WAS RECEIVING EFFECTIVE STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S PAIN WOULD PERSIST REGARDLESS OF THE INS HAVING BEEN ON OR OFF. THE PATIENT WAS WILLING TO DEAL WITH THE SITE PAIN AS THE THERAPY WAS "SO EFFECTIVE." IMPEDANCE TESTING WAS DONE, WHICH RETURNED VALUES INDICATING THAT ALL OF THE CONTACTS WERE WITHIN NORMAL LIMITS. NO DEVICE MALFUNCTION WAS SEEN AND THE CAUSE OF THE ISSUE HAD NOT BEEN DETERMINED. AN IMPLANT SITE REVISION HAD BEEN SCHEDULED TO OCCUR ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596149 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 00062 YR Required Intervention