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

Model Number	SC-8352-70
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation of the targeted pain area; bilateral back and legs.Multiple reprogramming attempts were made, however, only the left inner thigh was able to obtain coverage.An x-ray was performed which confirmed that the lead had migrated.The patient underwent a lead revision procedure where the lead was explanted and replaced.The patient is expected to fully recover.
Event or Problem Description
It was reported that the patient was experiencing inadequate stimulation of the targeted pain area; bilateral back and legs.Multiple reprogramming attempts were made, however, only the left inner thigh was able to obtain coverage.An x-ray was performed which confirmed that the lead had migrated.The patient underwent a lead revision procedure where the lead was explanted and replaced.The patient is expected to fully recover.
Additional Manufacturer Narrative
The returned lead was analyzed; passed all tests performed and exhibited normal device characteristics.Engineers have concluded that the reported event of lead migration, resulting in inadequate stimulation is a known inherent risk with implanting a pulse generator as part of a system to deliver spinal cord stimulation.

• Brand Name: COVEREDGE X 32
• Common Device Name: 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: 14432186
• Report Number: 3006630150-2022-02315
• Device Sequence Number: 5628760
• Product Code: LGW
• UDI-Device Identifier: 08714729832690
• UDI-Public: 08714729832690
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/23/2020
• Device Model Number: SC-8352-70
• Device Catalogue Number: SC-8352-70
• Device Lot Number: 7015475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown