Description of Event or Problem · 0
(FDA). (B)(6): COMPLAINANT AGAINST: MEDTRONIC (B)(4) 710 MEDTRONIC PARKWAY MINNEAPOLIS, MINNESOTA 55432-5604. DR. (B)(6) M.D. (DBA) (B)(6) LAST KNOWN ADDRESS OF RECORD: (B)(6). DEAR: (FDA) PLEASE BE ADVISED, THIS NOTICE OF CLAIM WAS SENT, RECEIVED AND SIGNED FOR VIA CERTIFIED USPS DELIVERY BY, (B)(4) OF MEDTRONIC AND OR HIS REPRESENTATIVE, ON FEB 24, 2025. MEDTRONIC DENIED ANY LIABILITY/RESPONSIBILITY VIA REPRESENTATIVE (B)(4) ON MARCH 13, 2025. THE FOLLOWING IS A SYNOPSIS OF THIS MATTER: ON (B)(6) 2024, I WAS UNDER THE SUPERVISION AND CARE OF DR. (B)(6) OF THE (B)(6). I WAS ALSO UNDER THE GUIDANCE AND SUPERVISION OF AN EMPLOYEE OF MEDTRONIC INC, (B)(4). MEDTRONIC IS THE: MANUFACTURER, (B)(4) AND PATIENT COORDINATOR FOR THE SPINAL CORD STIMULATOR. (B)(4) WAS THE AGENT RESPONSIBLE FOR OPERATIONAL GUIDANCE AND INSTRUCTION REGARDING USAGE OF THE SPINAL CORD SIMULATOR CONTROLLER, FOR: ADJUSTMENTS, SETTINGS AND ALL COMMUNICATIONS WITH DR. (B)(6) REGARDING THE EFFECTIVENESS AND USE OF THE SPINAL CORD SIMULATOR DEVICE. ON (B)(6) 2024, DR. (B)(6) DID PERFORM SURGERY, IMPLANTING THE SPINAL CORD SIMULATOR OTHERWISE KNOWN AS (SCS) FOR PURPOSES OF REFERENCE THROUGHOUT THIS DOCUMENT. ON (B)(6) 2024, I MET WITH DR. (B)(6) AND (B)(4), AT DR. (B)(6) OFFICE FOR A ONE-MONTH POST-SURGERY FOLLOW-UP. APPROXIMATELY TWO WEEKS PRIOR TO THIS VISIT, I STARTED EXPERIENCING EXTREME PAIN AND DISCOMFORT IN MY LEFT SIDE BACK (THORACIC REGION) AND LEFT SIDE ABDOMINAL REGION. THIS PAIN WAS NEW IN NATURE AND WAS NOT PRESENT PRIOR TO SURGERY. IT SEEMED APPARENT THAT THE PAIN WAS POST-SURGERY IMPLANT RELATED. WHEN INFORMED OF THIS NEW PAIN, DR. (B)(6) CLAIMED THAT THIS PAIN HAD NOTHING TO DO WITH THE SURGERY HE PERFORMED. DR. (B)(6) SIMPLY ATTRIBUTED THE PAIN TO SOMETHING WITH THE SIMULATOR DEVICE, SETTINGS OR OTHER THINGS LIKE A FRACTURED RIB. I WAS SENT OUT TO THE LOBBY TO WORK WITH (B)(4), EMPLOYEE OF MEDTRONIC, IN AN ATTEMPT TO FIND A REMEDY TO THIS PAIN. THROUGH UNSUCCESSFUL MANIPULATION AND FAILED ATTEMPTS INVOLVING THE CONTROLLER, MS. (B)(4) AND DR. (B)(6) WERE INFORMED THAT I EXPERIENCED NO VIBRATION OR STIMULATION WITH THE EXCEPTION OF MY LEFT LEG AND LEFT SIDE BACK AREA. THE (SCS) WAS CLEARLY DEFECTIVE. AN INTERCOSTAL NERVE BLOCK WAS PERFORMED AT (B)(6) MEDICAL CENTER, BY DR. (B)(6). DR. (B)(6) WHO NOTED THAT THE PAIN MAY BE RELATED TO POSITIONING OF THE LEFT SPINAL SIMULATOR LEAD OR FAULT DEVICE INDICATIONS. AN MRI WAS PERFORMED. THE RESULTS SHOWED INDICATIONS OF "EDEMA" NOT PRESENT PRIOR TO SURGERY. THE EDEMA OR "SWELLING MASS" IS EXTREME AND DEBILITATING. IT IS MY CONTENTION THAT: FAULTY LEAD PLACEMENT AND LACK OF EFFECTIVENESS OF THE (SCS) WAS THE PROXIMATE CAUSE OF THE PAIN. MEDTRONIC, INC. FAILED TO PROVIDE AN EFFECTIVE (SCS) DEVICE AS IT WAS PRESENTED BY THE MEDTRONIC REPRESENTATIVE, MS. (B)(4) AND DR. (B)(6). FURTHERMORE, MEDTRONIC MISREPRESENTED THE BENEFITS OF THE (SCS) THROUGH PROMOTION, LITERATURE AND OR ADVERTISING. TO DATE, I HAVE INCURRED OVER: (B)(6) DOLLARS IN MEDICAL BILLS RELATING TO THIS ISSUE. I WILL NOW REQUIRE FUTURE MEDICAL TREATMENT NEEDED, THROUGH PAIN MANAGEMENT. ALL MEDICAL BILLING AND DOCTOR NARRATIVES SUPPORTING THIS MATTER WERE INCLUDED IN THE DEMAND PACKAGE SENT TO (B)(4) OF MEDTRONIC). SINCERELY, (B)(6).