BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3172469 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10429
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 24, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; 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. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE ANALYSIS FOR INS (B)(4) REVEALED NO ANOMALY FOUND. DEVICE ANALYSIS FOR LEAD VA0LH2M032 REVEALED THE BRAID WIRE WAS BROKEN AND EXPOSED 19.5 TO 20.2 CM FROM THE DISTAL END. THE OUTER INSULATION IS PINCHED AND WORN.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS FOR LEAD VA07TLY001 REVEALED NO SIGNIFICANT ANOMALY. THE LEAD BODY OUTER INSULATION WAS CUT. DEVICE ANALYSIS FOR LEAD VA07JJ5004 REVEALED THE LEAD BODY CONDUCTORS WERE BROKEN AT THE ANCHOR SITE. FURTHER CLARIFIED THAT #1 AND #5 CONDUCTORS WERE BROKEN 28.9CM FROM THE DISTAL END.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID NEU_SILICONEANCHOR, PRODUCT TYPE: ACCESSORY. PRODUCT ID NEU_SILICONEANCHOR, PRODUCT TYPE: ACCESSORY. PRODUCT ID 977A260, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A JOLTING SENSATION ¿GOING THROUGH THE RIBS¿ SINCE LAST NIGHT AFTER IMPLANT. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE SPOKE WITH THE PATIENT AFTER IMPLANT AND THE PATIENT REPORTED THAT THE DEVICE WAS WORKING GREAT. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT FELL AND LOST STIMULATION IN BACK AND LEGS. THE PATIENT ALSO FELT ONLY BURNING AT THE POCKET AND MIDLINE WHEN THE STIMULATION WAS ON. IMPEDANCES WERE NORMAL BUT IT WAS FELT THAT THE LEADS WERE PULLED AT POCKET OR BLOCK. THE LEADS WERE ALSO PULLED DOWN. IT WAS NOTED THAT THE INS WAS ON CONTINUOUS, DUAL STIM MODE. BOTH OF THE LEADS WERE REPLACED. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED FOUR MONTHS LATER THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND "WIRES" WERE EXPLANTED ON (B)(6) 2014. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO FIND OUT MORE INFORMATION REGARDING THE EXPLANT OF THE DEVICES. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273211 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