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

Model Number	SC-8352-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the implant procedure of the spinal cord stimulation lead it was noted that spinal access was more challenging due to a previous fusion but following that, the lead placement was straight forward.The physician noticed a small amount of clear fluid in the wound during closure so he used a sealant in the event that the fluid was cerebrospinal fluid (csf) leakage.Over the next few days, the patient developed a severe headache which was consistent with a csf leak which also contributed to a lack of mobility.As this symptom persisted, the patient underwent an explant procedure to remove the lead.The patient had some post operative pain but is expected to fully recover.The lead will not be returned as it was disposed of by the medical facility.

• 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: 14215220
• Report Number: 3006630150-2022-01859
• Device Sequence Number: 14518335
• Product Code: LGW
• UDI-Device Identifier: 08714729832683
• UDI-Public: 08714729832683
• 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: 2022
• 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
• Report Date (Section B): 04/26/2022

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/30/2023
• Device Model Number: SC-8352-50
• Device Catalogue Number: SC-8352-50
• Device Lot Number: 7070164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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