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

Model Number SC-8336-70

Device Problems Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problems Neuropathy (1983); Pain (1994); Inadequate Pain Relief (2388)

Event Date 01/08/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-ipg-r, upn: m365sc11600, model: sc-1160, serial: (b)(4), batch: 372138.The paddle lead sc-8336-70 serial number (b)(4) and ipg sc-1160 serial number (b)(4) were not returned for analysis, as both devices were discarded by the facility.As such, physical analysis has not been conducted in our laboratory.However, a labeling review was conducted for both devices.This review determined that the inadequate stimulation was likely a result of lead migration which is a known inherent risk with use of implanting a pulse generator as part of a system to deliver spinal cord stimulation, as documented in the ifu.In addition, a review of the manufacturing documentation for the devices revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported that the patient experienced inadequate stimulation in his neck, shoulder, and arm pain.The patient developed a new onset of neuropathic pain in the left arm after the initial implant procedure.After numerous reprogramming attempts did not resolve the issue, the patient decided to undergo a revision procedure to explant the ipg and paddle lead.The explanted ipg and paddle lead were discarded by the facility.The patient is fully recovered.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12108959
• MDR Text Key: 259680245
• Report Number: 3006630150-2021-03441
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729832676
• UDI-Public: 08714729832676
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/29/2022
• Device Model Number: SC-8336-70
• Device Catalogue Number: SC-8336-70
• Device Lot Number: 7070333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2020
• 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