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 Codes	Unexpected Therapeutic Results (1631); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing loss of stimulation.It was stated that the patients paddle lead had moved and was confirm through imaging.The physician believed that it was due to a sneezing fit.The patient underwent a procedure wherein the lead was repositioned and that the patient was doing well postoperatively.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 16574121
• Report Number: 3006630150-2023-01377
• Device Sequence Number: 12254253
• Product Code: LGW
• UDI-Device Identifier: 08714729832683
• UDI-Public: 08714729832683
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2023

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: 09/13/2024
• Device Model Number: SC-8352-50
• Device Catalogue Number: SC-8352-50
• Device Lot Number: 7070479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Race: White