BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4047820 · Received August 29, 2014

    Report

    Report Number
    3004209178-2014-16119
    Event Type
    Injury
    Date Received
    August 29, 2014
    Report Date
    April 5, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 355029, LOT# N0051188, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: 377760, LOT# V014020, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V014129, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    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: 355029, LOT# N0051188, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: 377760, LOT# V014020, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V014129, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEY HAD BEEN ELECTROCUTED IN 2008 BY THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT ON (B)(6) 2014 THAT THERE WAS A LEAD FRACTURE. THE PATIENT STATED THAT ONE OF THE LEADS BROKE IN HER SPINE AND ¿CURLED UP.¿ THE PATIENT STATED THAT THIS ¿NEARLY PARALYZED HER.¿ IT WAS NOTED THAT SURGERY WAS DIFFICULT DUE TO SCAR TISSUE. THE PATIENT STATED THAT THIS WAS IN 2006 OR 2008. THE PATIENT STATED THAT SHE HAD SIX SURGERIES INCLUDING THE INITIAL IMPLANT BECAUSE SHE HAD ¿MALFUNCTIONS.¿ HOWEVER, THE PATIENT WAS UNCLEAR ON THE TIMELINE FOR ALL EVENTS. THE PATIENT STATED THAT A MANUFACTURER REPRESENTATIVE WAS PRESENT FOR ALL OF THE SURGERIES. THE PATIENT STATED THAT THE THERAPY WORKED WELL AS OF (B)(6) 2014. IT WAS LATER REPORTED THAT THE PATIENT HAD A LEAD FRACTURE AND SO NEW LEADS WERE PLACED (B)(6) 2008. THE CAUSE OF THE LEAD FRACTURE WAS NOT KNOWN. THE PATIENT HAD PERCUTANEOUS LEADS REMOVED AND REPLACED WITH A PADDLE LEAD. THE MANUFACTURER REPRESENTATIVE LEARNED OF THIS THE DAY BEFORE THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT # 3004209178-2014-16092, 3004209178-2011-05244, 3004209178-2014-15649, 3004209178-2014-16097.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530316 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention