BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NEUROMODULATION DEVICE

    MDR report key: 2982061 · Received February 28, 2013

    Report

    Report Number
    3007566237-2013-00621
    Event Type
    Injury
    Date Received
    February 28, 2013
    Report Date
    February 6, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3986A, LOT# N140442, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT# N138329, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V386351, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V375109, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37082-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-09, LOT# LC3722, IMPLANTED: (B)(6) 2005, PRODUCT TYPE ACCESSORY; PRODUCT ID 3487A-45, LOT# V029694, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REMOVED 6-7 MONTHS AGO. TWO WEEKS AFTER THE DEVICE WAS REMOVED, THE PATIENT DEVELOPED AN INFECTION AND "IT OPENED UP." WITHIN THE PAST MONTH OR SO SHE HAD BEEN IN PAIN. IT WAS STATED THAT PATIENT'S HEALTHCARE PROFESSIONAL (HCP) THOUGHT THERE WAS AN ANCHOR IN THE LEFT SIDE OF HER NECK. IT WAS STATED THAT THE PATIENT WAS WALKING WITH A CANE. SHE COULD NOT MOVE HER NECK AND WAS WEARING A BRACE. IT WAS STATED THAT "THE DOCTOR CUT THE HELL OUT OF HER SHOULDERS AND NECK." IT WAS ALSO MENTIONED THAT SHE DID NOT KNOW SHE WAS GETTING A RECHARGEABLE DEVICE PUT IN. MORE THAN TWO WEEKS LATER IT WAS REPORTED THAT THE ANCHOR OR "BB" WAS LEFT OVER FROM THE PROCEDURE THAT HAD OCCURRED IN (B)(6) 2012, WHEN HER CERVICAL INS SYSTEM WAS REMOVED. IT WAS STATED THAT CT SCAN SHOWED THE PRESENCE OF THE BB. IT WAS STATED THAT THE PATIENT ALSO HAD A METAL PLATE IN HER NECK. IT WAS NOTED THAT SOME OF PATIENT'S COMMENTS SEEMED IRRATIONAL AND THE PATIENT WAS MEDICATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION REPORTED THAT HEALTHCARE PROFESSIONAL (HCP) WAS UNAWARE OF ANY INFECTION AND WAS GOING TO FOLLOW UP WITH THE PATIENT TO CONFIRM. FURTHER FOLLOW-UP INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE PATIENT HAD SIGNIFICANT TENDERNESS OVER THE LEFT PARAMEDIAN REGION WHICH WAS CONSISTENT WITH A RETAINED RADIOLUCENT ANCHOR COMPONENT. THE PATIENT HAD A SURGICAL PROCEDURE ON (B)(6) 2013 AT TIME THE PLASTIC ANCHOR COMPONENT WAS RETRIEVED. IT WAS NOTED THAT THERE WAS AN ADJACENT "FIRM AREA" THAT WAS ALSO EXCISED WHICH HAD NO EVIDENCE OF A FOREIGN BODY IN IT. DURING THE SAME PROCEDURE, UNDER AP C-ARM FLUOROSCOPY, A RIGHT PARAMEDIAN RADIOPAQUE LESION WAS OBSERVED. DISSECTION DOWN THE LESION EXPOSED WHAT APPEARED TO BE A CONTACT FROM THE LEAD. THIS CONTACT WAS REMOVED AND FLUOROSCOPY EXAMINATION ASSURED THAT THERE WAS NO RESIDUAL MATERIAL. THE PATIENT WAS AWAKENED, EXTUBATED, AND TRANSFERRED TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87913 UNKNOWN NEUROMODULATION DEVICE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention