BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 4221399 · Received November 3, 2014

    Report

    Report Number
    3004209178-2014-20836
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    April 27, 2014
    Report Date
    October 7, 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 Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37714, SERIAL# (B)(4), IMPLANTED: (B)(4) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37714, SERIAL# (B)(4) IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6)2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(4) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 377875, LOT# V013122, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V008840, IMPLANTED: 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V013333, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# VA013RU, IMPLANTED: 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-56, LOT# VA013RU, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STARTED TO HAVE MUSCLE SPASMS IN THEIR LOW BACK AND SACROILIAC AREA WITH BOTH IMPLANTS WHEN USING THE STIMULATOR ABOUT ONE MONTH PRIOR. THE PATIENT NOTED THEY ADJUSTED STIMULATION AND STILL IT CAUSED TIGHTNESS. THE PATIENT DID NOT FALL OR HAVE ANY TRAUMA. THE PATIENT HAD SPOKEN WITH THEIR PHYSICIAN AND WAS REFERRED TO A PHYSICAL THERAPIST. THE PATIENT HAD TURNED THEIR STIMULATION OFF TWO DAYS PRIOR DUE TO PAIN THAT IT WAS CAUSING ON TOP OF THEIR REGULAR PAIN. THE PATIENT HAD BEEN TURNING THEIR STIMULATION OFF FOR PHYSICAL THERAPY. THE LAST TWO PHYSICAL THERAPY APPOINTMENTS THE PATIENT TURNED THEIR STIMULATION OFF AND FORGOT TO TURN IT BACK ON BECAUSE THEY FELT MUCH BETTER WITH IT OFF. THE PATIENT HAD INCREASED MEDICATION OVER THE PAST YEAR AND WAS TAKING SO MUCH MEDICATION THEY DID NOT NEED THE STIMULATOR ANYMORE. IT WAS NOTED THE HEALTH CARE PROFESSIONAL CHECKED THE PATIENT¿S DEVICE. THE EVENT WAS RELATED TO THE PROGRAMMING OF STIMULATION. IN JUNE THERE WERE NO ABNORMAL IMPEDANCES FOUND. THE DEVICE WAS INTERROGATED AND NOTED THAT THE PERIPHERAL LEADS WERE MAKING THE SPASMS WORSE WHEN THEY WERE TURNED ON. INTERVENTION INCLUDED ADDING TWO NEW PROGRAMS, DECREASING THE PULSE WIDTH, AND DELETING TWO PROGRAMS. THE PATIENT BEGAN PHYSICAL THERAPY AND MEDICATIONS WERE ADMINISTERED. FENTANYL WAS INCREASED TO 50 UG/HR Q 48 HRS. THE PATIENT ALSO HAD BILATERAL ILEOLUMBAR AND SACROILIAC LIGAMENT INJECTIONS. THERE WAS NO HOSPITALIZATION DUE TO THE EVENT AND THERE WAS NO INJURY TO THE PATIENT. A COUPLE MONTHS LATER THE FENTANYL PATCH WAS INCREASED. ADDITIONAL INFORMATION REPORTED THERE WAS AN OVERDISCHARGE AND SOME ELECTRODES WERE OVER 10,000 OHMS. THE EVENT WAS RELATED TO THE R ECHARGING PROCESS. IT WAS ALSO NOTED THE PATIENT HAD SACROILIAC AND GLUTEAL PAIN. THE EVENT WAS ONGOING AT THE TIME OF REPORT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT. REFER TO MANUFACTURER REPORT # 3004209178-2014-20833 THE PATIENT HAS MULTIPLE SYSTEMS AND IT WAS UNCLEAR WHICH SYSTEM PERTAINED TO THE EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE PATIENT NOTED USE OF THE PERIPHERAL NEUROSTIMULATION RESULTS IN INCREASED BILATERAL SACROILIAC/GLUTEAL PAIN. THE PATIENT HAD MUSCLE SPASMS TO LOW BACK AND SACROILIAC AREAS WITH USE OF SPINAL CORD STIMULATOR. THERE WAS TIGHTNESS TO LOW BACK AREA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE EVENT WAS UNRESOLVED WITH NO FURTHER ACTIONS PLANNED. THE DEVICE DIAGNOSIS WAS LEAD HIGH IMPEDANCE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) OF A CLINICAL STUDY REPORTED THAT THE DEVICE DIAGNOSIS WAS HIGH IMPEDANCE. THE CLINICAL DIAGNOSIS WAS INCREASED PAIN TO SACROILIAC/GLUTEAL SECONDARY TO USE OF IMPLANTABLE NEUROSTIMULATOR (INS). THE ETIOLOGY WAS NOTED TO THE LEAD LOT NUMBER VA013RU WHICH WAS CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS) SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701514 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR