BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY COMPACT

    MDR report key: 4021344 · Received August 19, 2014

    Report

    Report Number
    3004209178-2014-15543
    Event Type
    Injury
    Date Received
    August 19, 2014
    Report Date
    July 25, 2014
    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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# V009352, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION. THE NIGHT PRIOR TO THE REPORT, THE PATIENT HAD STIMULATION OFF AND WAS SITTING IN A CHAIR. HE HAD A SHARP PAIN, FURTHER DESCRIBED AS A SHARP JOLT BY THE BATTERY AND IT HURT LIKE A SHOCK. THE PATIENT DID NOT CALL HIS PHYSICIAN. THE PATIENT USUALLY ONLY USED THE DEVICE ONCE DAILY AROUND NOON FOR AN HOUR. THE PATIENT HAD USED THE DEVICE THAT DAY, BUT HAD TURNED IT OFF AT 1PM. THE SHOCK HAPPENED AROUND 7-8PM. THE STIMULATOR AREA FELT AS IF THE SKIN WAS NOT AS TIGHT AS IT USED TO BE. THE PATIENT WAS ABLE TO MOVE THE STIMULATOR AND ABLE TO FEEL THE LEADS. THE PATIENT COULD NOT DO THIS PRIOR. THE AREA WAS NOT SWOLLEN AND THE PATIENT HAD NOT GAINED OR LOST ANY WEIGHT. OF NOTE, WHEN THE PATIENT PUSHED THE POWER BUTTON, IT DID NOT REQUIRE HIM TO SYNC BEFORE GOING TO THE MAIN SCREEN. THERE WAS NO LIGHTNING BOLT, AND IT WAS VERIFIED THE DEVICE WAS OFF. THE PATIENT DID NOT WANT TO TURN IT ON, BUT RATHER, WANTED IT REMOVED AS IT HAD BEEN NO USE TO HIM. THE PATIENT ALSO STATED THAT SINCE IMPLANT, STIMULATION HAD NOT HELPED HIS BACK PAIN AT ALL. HE ONLY FELT STIMULATION IN HIS FEET. THE DEVICE HAD BEEN REPROGRAMMED AT LEAST 3 TIMES AND IT HAD NOT HELPED AT ALL. THERE HAD BEEN NO FALLS OR TRAUMA. PHYSICIAN LISTINGS WERE GIVEN TO THE PATIENT. THE PATIENT HAD A PHYSICIAN THAT COULD EXPLANT THE STIMULATOR (AS PREVIOUSLY REPORTED) BUT WAS NOT SURE HOW TO EXPLANT THE LEADS. ADDITIONAL INFORMATION ABOUT THE OUTCOME WAS REQUESTED. IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2014. IT WAS REPORTED THAT THE HEADER BLOCK WHERE THE LEADS CONNECT LOOKED LIKE IT "SHATTERED" AND WAS BROWN UNDERNEATH IT. IT WAS ALSO NOTED THAT THE PATIENT WAS IN A LOT OF PAIN FOR THREE WEEKS BECAUSE OF THE PREVIOUS ISSUES WITH THE DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. SINCE IMPLANT, IT NEVER WORKED. THE PATIENT HAD THE BATTERY PACK REMOVED IN THE BACK. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TAKEN OUT THE PAST (B)(6) 2014 AND IT WAS REMOVED BECAUSE IT NEVER WORKED AND HAD GOTTEN VERY PAINFUL AT THE LOCATION. THE BATTERY PACK WAS BOTHERING THE PATIENT IN WHEN HE HAD IT IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WANTED THE STIMULATOR REMOVED AS IT WAS CAUSING HIM PAIN DUE TO BEING AT HIS BELT LINE. THIS HAD BEEN BOTHERING HIM FOR SOME TIME. THE PHYSICIAN WAS ONLY GOING TO REMOVE THE STIMULATOR BECAUSE THE PATIENT COULD NOT FIND ANYONE TO REMOVE THE WHOLE SYSTEM. THE PHYSICIAN MENTIONED CUTTING THE LEADS. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497945 SYNERGY COMPACT STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7479B

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Required Intervention