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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC PRECISION SPINAL CORD STIMULATOR

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BOSTON SCIENTIFIC BOSTON SCIENTIFIC PRECISION SPINAL CORD STIMULATOR Back to Search Results
Device Problems Break (1069); Fracture (1260); Temperature Problem (3022)
Patient Problems Muscle Weakness (1967); Pain (1994); Weakness (2145); Numbness (2415); Neck Pain (2433); Ambulation Difficulties (2544)
Event Date 09/24/2017
Event Type  Injury  
Event Description
Attached for your convenience is the fax sent to you on (b)(6) 2017.If you will recall, you called my husband on (b)(6) 2017, indicating i had sent the documents to the right place to make a claim.I have repeatedly asked for help but have been ignored.I also attached a copy of an x-ray showing the fractured leads and hardware failure, along with records from (b)(6) medical center showing the hardware/device malfunction.I asked for the damaged battery, leads and device but was denied.I do have the remote and charger for the device along with the identifiers on the wallet card.As i previously indicated to you, since the failure and subsequent removal of the device, my husband has become bedridden and confined to a wheelchair.Although disabled prior to the implant, (b)(6) was able to perform everyday tasks and be independent.Now, he has to rely on me to assist him.To be quite blunt, i have to wipe his behind.Very little changed since the removal (3rd surgery).On the day following the surgery, we expected minimal pain, and everything to go back to the way it was before the surgery.Sadly, that was not and is not the case.As my husband awoke 2 days postop, he complained that he could not move his arms and legs - he could feel them but not move them.This went on for approx 6 months.Several hours after becoming awake he could move his arms and legs with difficulty.He was extremely weak and unable to support or carry his own weight.The battery site and his incision site became extremely painful.At present, (b)(6) experiences not knowing what part of his body will become immobile.He is confined to bed.Mentally and physically it is destroying him.Since the malfunction and removal, he has suffered and gone through an immeasurable amount of pain and anguish.He has no quality of life, and this not only affects him but our family.I am beginning to see skin break down, even though i try to move him as much as possible.The damage done by the malfunction of your device is permanent and irreversible.Medical and physical care from this will be life long as there will be no end to his suffering and permanent damage.We have absorbed the cost for some of (b)(6) needs.However, continue to do so and knowing that his needs are a direct result of the damage caused by your system failing is an unfair burden on our family.(also, we are not financially able to continue to do so) in that regard, i have attached a list of measures we have taken, and the future expenses we will encounter in order for (b)(6) to have any quality of life.My husband is (b)(6).His life expectancy according to sc code section (b)(4) is 35.53 years.Please advise me what we need to do to file a claim.Thanks.(b)(6) 2014, he had a boston scientific precision spinal cord stimulator implanted.On (b)(6) 2014, after complaining to his physician that the device was painful and it was ascertained that there was malfunctioning - lead and it appeared that the lead had been "fractured." the battery site was also hot to the touch and painful.It was determined that he needed a revision.On (b)(6) 2014, the surgeon revised the stimulator.The battery was replaced.He also placed new percutaneous lead (16 contact lead).After the revision, my husband experienced constant pain.The stimulator seemed to be limiting his left arm even more and affecting his ability to grip even more than the natural progressive decline that is occurring.It began causing him more pain in his neck, middle and lower back.He had full feeling prior to the stimulator in all fingers and now has advanced tingling in his left thumb pointing finger and middle finger.The reinforcement placed by the surgeon was oddly uncomfortable.The base of his neck felt as if being poked by the leads, leaving my husband to lie in bed in a specific uncomfortable position causing him much discomfort.The battery of the device is uncomfortable and is at times painful to the touch and red and puffy.The pain was debilitating.We were told that my husband would experienced a "warming feeling", however, instead, the feeling of electric pulses that aren't making it to his right arm, but mainly staying on his left side is not an adjustment that boston scientific can do.So we began to seek removal of the device.On (b)(6) 2015, the device was removed.Since removal of stimulator, my husband has experienced pain and extremity weakness.The incision site and battery site are extremely raised with a very large "lump." underneath.I have attached just a few of the hospital records.As you can see, all of the diagnosis codes/reasons appear to be "hardware malfunction." (b)(6) 2016 and (b)(6) 2016, mris of the cervical and lumbar spine were done.The results showed multiple changes to include stenosis, bulging and a tear in discs to name just a few.After watching my husband suffer with no relief i took his health care in my own hands, and scheduled an appointment with lexington brain and spine.For his cervical spine-on page 4 it says that (b)(6) issues are related to the implantation and explantation of the stimulator.For his lower back it was explained that a fusion was necessary, however, because of his age, recommendation of dr and the recovery time and down time the fusion isn't something he wants to do at this time.He would like to try injections and if it doesn't work, we will discuss the "smaller surgery" which is the laminectomy and the discectomy.(b)(6) has been bedridden since removal of stimulator.He has bouts of paralysis which can occur in and out of bed.He experiences severe charlie horses.He can't said stand for more than a few mins, cannot bear weight on his legs and is mostly confined to the bed.He can no longer take care of personal hygiene without assistance.To put it bluntly, i bathe him and wipe his behind.Any help or assistance that can be provided would be appreciated.
 
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Brand Name
BOSTON SCIENTIFIC PRECISION SPINAL CORD STIMULATOR
Type of Device
BOSTON SCIENTIFIC PRECISION SPINAL CORD STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key7200234
MDR Text Key97705671
Report NumberMW5074627
Device Sequence Number2
Product Code GZB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/12/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Age44 YR
Patient Weight100
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