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

Model Number SC-1132

Device Problem Insufficient Information (3190)

Patient Problems Reaction (2414); No Code Available (3191)

Event Date 01/20/2017

Event Type  Injury  

Event Description

I had a spinal cord stimulator, boston scientific precision spectra, implanted on (b)(6) 2016.On (b)(6) 2017, met the b.S.Rep because stimulator was not holding a charge.I was told that nothing could be done about this.About (b)(6) 2017 began having symptoms of serotonin syndrome.I reported this to my pain management physician and surgeon.The b.S.Rep (b)(4) told both of them this was impossible research, however, describes evidence that a stimulator increases serotonin levels.Symptoms became increasingly worse.Both physicians advised me to shut the stimulator off.When i did symptoms improved markedly.When i turned it on again (at the urging of my physician) the symptoms returned.The decision was made to leave the stimulator off.On (b)(6) 2017, the stimulator was explanted on an emergent basis.As of today (b)(6) 2017 i am still having symptoms of serotonin syndrome.The symptoms are gradually improving i am hoping they will entirely resolve.I was seen in an ed on (b)(6) 2017 for treatment of symptoms.Although boston scientific does not want to admit that spinal cord stimulators cause serotonin syndrome they should be forced to research this.I have found several people with this reaction.And in the (b)(6) 2017 edition of the journal pain, a case study is presented of a pt with a stimulator who also developed serotonin syndrome.I am told that in some army hospitals this issue is recognized and pts who are on ssri's are weaned off of them before implant to prevent serotonin syndrome.I was not warned of this issue, was not weaned off of ssri's, and i developed what could have been a fatal complication.Please force boston scientific and other mfrs to perform research on this topic.Right now the companies are earning huge profits from the stimulators and are pushing these for that reason.But they are falling down on the job if they do not follow through and report this reaction widely.My two physicians are now well aware of the possibility of serotonin syndrome.But when they had a rep telling them it was unheard of, they believed her initially.Dangerous.Ref mfr report # 3006630150-2017-00584.

• Brand Name: PRECISION SPECTRA SPINAL CORD STIMULATOR
• Type of Device: PRECISION SPECTRA SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6553764
• MDR Text Key: 74823060
• Report Number: MW5069623
• Device Sequence Number: 1
• Product Code: LGW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC-1132
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FISH OIL; PROBIOTIC; VITAMINS
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 65 YR
• Patient Weight: 77