MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PRECISION SPECTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF.

Model Number SC-1032B

Device Problem Material Protrusion/Extrusion (2979)

Patient Problems Arthritis (1723); Emotional Changes (1831); Headache (1880); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Scarring (2061); Tissue Damage (2104); Weakness (2145); Burning Sensation (2146); Malaise (2359); Depression (2361); Numbness (2415); Dysuria (2684); No Code Available (3191)

Event Date 10/01/2016

Event Type  Injury  

Event Description

My husband (b)(6) has had 2 boston scientific stimulators push through the skin on his buttocks and eject themselves from his body.He has had massive infections and side effects and disorders left over from the units being in his body.These units were burning inside of him causing a burning sensation in the area where the battery pack was inside his body and the outside body temperature in that area was higher than that of a fever of 104-106 degrees.It had caused the skin to burn and scar, turning different colors in those areas.My husband complained to the company representative and doctors that the side effects from the units were a metallic taste like pennies in his mouth, a burning pain running up and down his spine where the leads were, some problems like nerve damage, removing bone with intense pain afterwards, scar tissue damage, scars, healing time, surgical pain, the intense trauma around the spine, not to mention allergic reactions, severe reactions, staph with a chance of mrsa, hep b, contracting anything under the sun, blood loss, loss of feeling, more pain, burning in the spine, burning while charging your unit, intense pain in the site after removal, a feeling of unwell or sickness at all times, depression, not being able to take care of your family, feeling like a burden on your family, not being able to urinate, the unit shocking you without cause, the unit turning on and not turning off, the feeling of being fried by the unit, change in moods, wanting to die, the unit ejecting itself from your body, not being able to perform sexually with your partner, no erections, headaches, loss of use of hands and feet, numbness in hands and feet, coldness in hands and feet, fever, squealing in ears, pain in battery area after its out.Those are all things my husband experienced, now he has these patches of redness almost like psoriatic arthritis popping up all over his body, severe pain.My husband also was on antibiotics to fight infections from this unit over 26 times in one year and that did not include the times he was on iv antibiotics.This unit has caused my husband permanent infection.We have been using scs units for years and the one thing we have noticed is the exterior of the medtronic unit my husband had in his flank on 2003-2008 was a design that did not look pieced together.The scs from boston scientific had a seam that ran down the middle of the unit like it snapped together.I have the boston unit in my possession and the medtronic unit did not have this seam.This has always caused some alarms, questions and concerns in our mind that this is the reasons for the infections.The seams would harbor great amounts of bacteria in it.When my husband first got the stimulator out and was told he had an infection we had to go to the infectious disease doctor here at (b)(6) hospital and the room that patients were being treated in was big enough to hold the reclining chairs for the patients to have iv therapy for hours on end, so my husband and i would sit and chat with the patients and their spouses to find out that everyone in this room was from the same doctor putting in these spinal cord stimulators, everyone had infections from these units, he only places the boston unit here on the panhandle and had concerned the market until about a year ago.Recently he has had a patient die from an infections from a boston scientific stimulator that could not be cured.I was in the surgical field for 21 years and this has always concerned me the say that this unit had a seam and could harbor the bacteria.(b)(6) had explained to me the look of the older medtronic units and that it did not look pieced together like it snaps together.I know sterilization protocol and highly doubt that they are making these in a sterile environment.These are probably snapped together in a 3rd world country, by 5 year old's after picking their noses and we are paying the price for it.Staph infections all around.Please save other people from what my husband has endured.Fda safety report id # (b)(4).

• Brand Name: PRECISION SPECTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF.
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 8906057
• MDR Text Key: 155552775
• Report Number: MW5089098
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 08/14/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC-1032B
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Disability
• Patient Age: 55 YR
• Patient Weight: 87