BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3002599 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03667
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 25, 2013
    Report Date
    April 11, 2017
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39, LOT# N331050, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (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. PRODUCT ID: 3550-39, LOT# N331050, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AT FIRST THE PATIENT NOTICED SOMETHING WAS NOT RIGHT A MONTH AFTER THE IMPLANT, AND AN X-RAY IN (B)(6) CONFIRMED THE LEADS WERE DISLODGED. THE PATIENT WAS SCHEDULED FOR SURGERY ON (B)(6) 2013 TO FIX THE LEADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS MIGRATED, STIMULATION WAS IN THE WRONG LOCATION, AND THERE WAS A LOSS OF STIMULATION/THERAPEUTIC EFFECT. THE PATIENT REPORTEDLY DID NOT RECEIVE STIMULATION INTO HER BACK, WHICH WAS ONE AREA SHE NEEDED COVERED. AN X-RAY REVEALED THAT BOTH LEADS MIGRATED. IT WAS STATED THAT BOTH LEADS HAD BEEN POSITIONED AT THE BOTTOM OF T6 VERTEBRA AT TIME OF SURGERY. AN X-RAY SHOWED ONE LEAD AT T7 VERTEBRA AND THE OTHER AT T8-9 VERTEBRAE. IT WAS NOTED THAT THE PATIENT WILL BE UNDERGOING A LEAD REVISION TO REPOSITION THE LEADS TO THE APPROPRIATE LEVEL. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT UNDERWENT LEAD REPLACEMENT ON (B)(6), 2013. SHE WAS SEEN FOR A POST-OPERATIVE FOLLOW-UP APPOINTMENT AND HAD APPROPRIATE STIMULATION, WITH ONLY VERY MINOR RIB STIMULATION ON THE LEFT SIDE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2017-03-20. THE PATIENT REPORTED THAT HER LEADS WEREN¿T WORKING. THE PATIENT REPORTED THAT THE LEADS WERE REPLACED AND AT THE SAME TIME THE NEUROSTIMULATOR (INS) WAS MOVED DEEPER INTO THE POCKET. THE PATIENT REPORTED THAT THE INS REVISION WAS DONE NOT DUE TO AN ISSUE BUT SHE THOUGHT THE HEALTHCARE PROVIDER (HCP) THOUGHT IT WAS TOO CLOSE TO THE SURFACE. THE PATIENT REPORTED THAT SINCE THAT TIME, SHE HAD TO STAND TO RECHARGE. NO FURTHER COMPLICATIONS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106036 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 45 YR Required Intervention