MAUDE Adverse Event Report: ST. JUDE MEDICAL/ABBOTT MEDICAL SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 3788ANS

Device Problems Device Slipped (1584); Malposition of Device (2616); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Unspecified Infection (1930); Pain (1994)

Event Date 10/10/2019

Event Type  Injury  

Event Description

Date listed as date my spinal cord stimulator implant (orig from st.Judes, (b)(6) 2014) was fully replaced at (b)(6).Reqd 2 days in hosp; subsequent infections from stay, allergies to antibiotic (ancef) and other adverse reactions to surgery itself.Dr may have reported (hopefully) this surgery to fda.I am reporting surgery and other side effects of scs.At some point, battery pk must¿ve slipped lower in my rt buttock, causing excruciating, radiating pain down my rt hip and leg.This was main reason for surgery, to move battery to another location.I run unit 24/7 for pain management, and at high levels, so it qas decided that battery should be replaced at same time.Earlier this year, it was noted that a critical lead had failed.This lead then inexplicably started working a few months later (i could feel when nit would stop and start) but testing showed tolerances were way off and lead was failing when it was working.So instead of 2 surgeries, dr and myself agreed to fix lead same surgery.During pre-op day of surgery, it was determined that a 2nd lead was failing/wires were found to be crossed.So entire system was replaced during surgery, as well as mew battery implant/move.Abbott is new mfr since they bought st judes a few years ago.I noticed within last year or two increased lbl-light bladder leakage.I attributed this to age, i am now (b)(6).I had a full hysto, leaving 1 ovary in (b)(6) 2019.Lbl completely unchanged.After scs surgery, my new unit was left off for 2wks per dr orders.I had run the unit 24/7 since implant, aside from one 12hr period a few hrs back when battery died/waiting for new charger.I depend upon unit for pain management.(meds from surgery seemed to control pain until it was time to turn back on.) i noticed that with unit off for 1st time, my lbl instantly stopped.Completely.It has instantly returned now that unit is back on.Therefore, i can conclusively state 110% that my scs in tonic mode causes lbl.Unit fr 2014 repl 2019.Fda safety report id (b)(4).

• Brand Name: SPINAL CORD STIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): ST. JUDE MEDICAL/ABBOTT MEDICAL
• MDR Report Key: 9260505
• MDR Text Key: 164843234
• Report Number: MW5090789
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/28/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3788ANS
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 50 YR
• Patient Weight: 68