BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4130013 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-17997
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 97754, 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 A GRADUAL LOSS OF STIMULATION AND THERAPEUTIC EFFECT. A REVISION WAS PERFORMED TO CORRECT THE ISSUE. DURING THE REVISION THE DOCTOR RE-CONNECTED THE LEADS TO THE IMPLANTABLE NEUROSTIMULATOR (INS). THE LEADS WERE NOT COMPLETELY INSERTED INTO THE HEADER OF THE BATTERY INITIALLY. DURING THE REVISION THE LEADS WERE FULLY INSERTED INTO THE INS HEADER. AFTER THE REVISION THE PATIENT WAS DOING WELL WITH APPROPRIATE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT STIMULATION WAS IN THE WRONG LOCATION. THE PATIENT WAS IMPLANTED WITH A NEW IMPLANTABLE NEUROSTIMULATOR (INS) ON THE DAY PRIOR TO THE DATE OF THIS REPORT. THE MANUFACTURING REPRESENTATIVE HAD COME IN ON THE DATE OF THIS REPORT AND WAS UNABLE TO GET THE INS WORKING, STIMULATION WAS NOT GOING TO THE CORRECT AREA. THE PATIENT KNEW HIS LEAD WIRES HAD NOT BEEN PLACED CORRECTLY BECAUSE THE STIMULATION WAS GOING IN THE STOMACH AND IN THE LEFT LEG BUT WAS SUPPOSED TO BE IN THE RIGHT LEG AND LOWER BACK. UPON MEETING WITH THE PATIENT ON (B)(6) 2014 IT WAS DETERMINED THEY WOULD BE REFERRED TO ANOTHER HEALTH CARE PROVIDER (HCP) ON (B)(6) 2014 FOR A POSSIBLE REVISION OF THE LEAD HOWEVER NO ACTION HAD BEEN TAKEN OR PLANNED. THE PATIENT WAS NOT USING THEIR STIMULATOR BECAUSE IT WAS IN THE WRONG LOCATION IS PAINFUL. AS A RESULT OF NOT USING THEIR DEVICE THEY WERE NOT RECEIVING 50% THERAPY RELIEF. ON (B)(6) 2014 THE PATIENT WAS SEEN BY THEIR HEALTH CARE PROVIDER (HCP) AND AN IMPEDANCE CHECK WAS PERFORMED. IT WAS FOUND CONTACTS 8-10 AND 13-15 SHOWED IMPEDANCES GREATER THAN 10,000 OHMS. THE PATIENT WAS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2014. (B)(4). ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608780 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention