BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3013928 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-04016
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    September 12, 2016
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES: THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE:: PRODUCT ID: 37742, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3487A, LOT# L65022, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-33, LOT# J0511393V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: RECHARGER: PRODUCT ID 37742, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006. PRODUCT TYPE: EXTENSION: PRODUCT ID 3487A-33, LOT# J0511393V, IMPLANTED: (B)(6) 2006. PRODUCT TYPE: LEAD: PRODUCT ID 3487A, LOT# L65022, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEFT LEAD WAS "BROKEN AND DIDN'T WORK RIGHT." IT WAS ALSO NOTED THAT THE LEAD WAS STICKING OUT OF THE PATIENT'S SPINE, "LIKE IT WAS COMING THROUGH THE SKIN." ADDITIONALLY, STIMULATION WAS INTERMITTENT ON THAT LEAD. THE REPORTER INDICATED THAT THE PATIENT WAS WORKING WITH HER HEALTHCARE PROVIDER (HCP) TO FIX THE ISSUE. THE PATIENT WAS INFORMED THAT SHE WAS GOING TO NEED A REVISION ON THAT LEAD. IT WAS ALSO NOTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR ALSO NEEDED TO BE REPLACED SINCE THE PATIENT HAD IT FOR 7 YEARS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THEIR PREVIOUS SYSTEM COMPLETELY REMOVED AS ONE OF THE LEADS WAS BROKEN AND HAD A SHORT. IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEPLETING ALL THE TIME. THEY STATED THAT ONE OF THEIR LEADS WAS REMOVED AS IT WAS AN OLDER LEAD. THE PATIENT ALSO MENTIONED THAT THEY FALL ALL TIME AND HAVE NO BALANCE. NO PATIENT SYMPTOMS WERE REPORTED. INDICATIONS FOR USE ARE SPINAL PAIN, CHRONIC LOW BACK PAIN, AND LUMBAR RADICULOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115909 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention