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

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.

• 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 Key: 10695565
• MDR Text Key: 211872623
• Report Number: 3006630150-2020-04916
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832669
• UDI-Public: 08714729832669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• 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 Date: 08/26/2022
• Device Model Number: SC-8336-50
• Device Catalogue Number: SC-8336-50
• Device Lot Number: 7072353
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/19/2020
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male