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	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced inadequate stimulation due to high impedances on the lead following a revision procedure reported in manufacturer report 3006630150-2023-05955.The patient underwent a lead replacement procedure and was doing well postoperatively.
Additional Manufacturer Narrative
Analysis of the lead revealed that visual inspection of the paddle lead showed it was cleanly cut into five pieces, approximately 52 cm from the proximal end of the lead.The clean-cut damage is a result of a typical explant procedure, and it is not considered a failure.No other anomalies were identified aside from the clean cut.A labeling review determined that the event of inadequate stimulation due to high impedances on the lead is a known inherent risk of the device as documented in the ifu.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient experienced inadequate stimulation due to high impedances on the lead following a revision procedure reported in 3006630150-2023-05955.The patient underwent a lead replacement procedure and was doing well postoperatively.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 18172873
• Report Number: 3006630150-2023-07201
• Device Sequence Number: 20805710
• 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: 2017
• Device Explanted Year: 2023
• 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): 02/07/2024

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: 09/15/2018
• Device Model Number: SC-8352-70
• Device Catalogue Number: SC-8352-70
• Device Lot Number: 19720485
• 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: 11/06/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2016
• 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