BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3242684 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12158
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 1, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013: PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013: PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID 37754, 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURER REPRESENTATIVE (REP) COULD NOT VALIDATE THE ISSUES REGARDING TELEMETRY. IT WAS REPORTED ¿EVERYTHING WORKED FINE FROM THAT RESPECT WORKED FINE¿. IT WAS NOTED ONE LEAD WAS ENTIRELY OUT OF NORMAL IMPEDANCE RANGE. IT WAS REPORTED ¿PROGRAMMED ON OTHER LEAD¿. IT WAS LOGGED THEY ACHIEVED TEMPORARILY SATISFACTORY STIMULATION. IT WAS REPORTED THEY WERE UNAWARE OF ANY INTERVENTION PLANNED FOR (B)(6). IT WAS REPORTED THE REP HAD NO WAY TO VALIDATE NORMAL RECHARGE INTERVALS VERSUS PATIENT REPORT IN TERMS OF EXPECTED VERSUS ACTUAL RECHARGE INTERVAL. IT WAS NOTED THE PATIENT REPORT MATCHED THE RECHARGER LOGS PULLED ON THE CLINICIAN PROGRAMMER. IT WAS REPORTED THE PATIENT HAD A SIGNIFICANT FALL SINCE IMPLANT. IT WAS REPORTED THE REP COULD NOT TEMPORALLY CORRELATE THE NEUROSTIMULATOR PROBLEMS WITH THE INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED REPROGRAMMING WAS PERFORMED AS A RESULT OF THE HIGH IMPEDANCE. IT WAS STATED THAT X-RAYS WERE ALSO PERFORMED AND THE X-RAYS HAD COME BACK INCONCLUSIVE. IT WAS STATED THAT THE PATIENT IDENTIFIED A TIME WHEN THEY LIFTED A (B)(6) PATIENT OFF OF THE FLOOR AFTER A FALL AND THEY HAD FELT A PULL AND PAIN. IT WAS STATED THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE AND NO INJURY. FOLLOW UP WAS REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FRACTURED LEAD. HIGH IMPEDANCES WERE OBSERVED. IMPEDANCES TESTING SHOWED 40,000 OHMS ON CONTACTS 8 AND 14. THE HEALTH CARE PROFESSIONAL (HCP) WANTED TO WAIT TO REVISE UNTIL PATIENT LOST EFFECTIVE THERAPY. PATIENT HAD HAD MULTIPLE FALLS AND THIS WAS THE CAUSE OF THE ISSUE. PATIENT WAS GOING TO HAVE AN MRI OF HER HEAD. NO SYMPTOMS WERE REPORTED WITH THIS EVENT. PATIENT WAS GETTING GREATER THAN 50% PAIN RELIEF. HCP WOULD NOT EXPLANT UNTIL THE PATIENT BECOMES SYMPTOMATIC.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE PATIENT WOULD TRY A NEW PROGRAM TO DECIDE IF THAT PROGRAM WOULD BE SUFFICIENT TO COVER THEIR PAIN OR IF THEY NEED TO OPT FOR A REVISION SURGERY. THE PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION RECEIVED REPORTED A LEAD WAS CRACKED SINCE (B)(6) 2013 AND IT WAS TURNED OFF. IT WAS NOTED THE LEAD(LEFT) WAS SHUT OFF THE WEEKEND PRIOR TO REPORT AND THE RIGHT LEAD WAS STILL WORKING. IT WAS LOGGED THE PATIENT WAS GOING THE TUESDAY FOLLOWING REPORT FOR A SURGERY ON THE IMPLANT. IT WAS REPORTED THE PATIENT HAD GAINED WEIGHT SINCE HAVING THE INS AND IN THE BEGINNING IT WAS WORKING TO HELP CONTROL THE PAIN. IT WAS ALSO REPORTED THE PATIENT HAD TROUBLE RECHARGING IT AS WELL, BUT SHE HAD A FULL BATTERY. IT WAS REPORTED THE PATIENT WAS FEELING THE STIMULATION AND WANTED TO TURN IT UP BUT THE PROGRAMMER WAS GETTING A NO COMMUNICATION SCREEN EVERY TIME SHE USED IT. IT WAS LOGGED THE BATTERIES WERE REPLACED AND "REPOSITIONED THE SCREEN" AND STILL DID NOT CONNECT. IT WAS REPORTED THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT THE ANTENNA ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342584 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 Required Intervention