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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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BOSTON SCIENTIFIC NEUROMODULATION COVEREDGE 32; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number SC-8336-50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Paralysis (1997); Deformity/ Disfigurement (2360); No Code Available (3191); Unspecified Mental, Emotional or Behavioural Problem (4430); Sexual Dysfunction (4510)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-ipg-r.Upn: (b)(4).Model: sc-1160.Serial: (b)(4).Batch: 371000.Product family: scs-lead fixation.Upn: (b)(4).Model: sc-4316.Serial: na.Batch: 25527904.
 
Event Description
It was reported that upon receiving post-operative tests, immediately after the implant procedure and before stimulation was turned on, the patient experienced paralysis in his lower body.Patient immediately underwent a procedure to explant all of the implanted components, and a decompression laminectomy was performed.It was suspected that the cause of the neurological symptom was due to lack of space in the spinal canal, and it was unknown if the paralysis was device related.Paralysis in the lower body lasted for 4 days, and post-operatively the patient is improving slightly and is at a rehabilitation center.All items were discarded and will not be returned for analysis.
 
Event Description
It was reported that upon receiving post-operative tests, immediately after the implant procedure and before stimulation was turned on, the patient experienced paralysis in his lower body.Patient immediately underwent a procedure to explant all of the implanted components, and a decompression laminectomy was performed.It was suspected that the cause of the neurological symptom was due to lack of space in the spinal canal, and it was unknown if the paralysis was device related.Paralysis in the lower body lasted for 4 days, and post-operatively the patient is improving slightly and is at a rehabilitation center.All items were discarded and will not be returned for analysis.Additional information was received that the patient had first undergone a bilateral decompressive laminectomy of the 9-10 thoracic vertebrae for the placement of the spinal cord stimulation (scs) system.A post-operative computer tomography (ct) reflected spinal cord compression at the level of the 8-9 thoracic vertebrae.A second bilateral decompression laminectomy was then performed, at the level 8-9 and 9-10 thoracic vertebrae, in response to the patient's postoperative paralysis.Additionally, it was reported the patient had sustained a spinal cord injury that caused paraplegia and other related injuries including pain, emotional distress, disability and disfigurement, and sexual dysfunction.
 
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Brand Name
COVEREDGE 32
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key10695565
MDR Text Key211872623
Report Number3006630150-2020-04916
Device Sequence Number1
Product Code LGW
UDI-Device Identifier08714729832669
UDI-Public08714729832669
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030017
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date08/26/2022
Device Model NumberSC-8336-50
Device Catalogue NumberSC-8336-50
Device Lot Number7072353
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/01/2020
Initial Date FDA Received10/19/2020
Supplement Dates Manufacturer Received10/13/2022
Supplement Dates FDA Received10/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age76 YR
Patient SexMale
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