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

Model Number	SC-8436-50
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994); Paralysis (1997)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the recently implanted patient experienced loss of function in their legs and experienced severe pain.A magnetic resonance imaging (mri) was performed which revealed two hematomas.The patient underwent an explant of the entire system.The patient has regained function in their legs and the pain has improved.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event product family scs-ipg-r-mri.Upn m365sc12320, model sc-1232, serial-lot (b)(6), batch 755385.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event product family scs-ipg-r-mri.Upn m365sc12320.Model sc-1232.Serial-lot (b)(6).Batch 755385.
Event or Problem Description
It was reported that the recently implanted patient experienced loss of function in their legs and experienced severe pain.A magnetic resonance imaging (mri) was performed which revealed two hematomas.The patient underwent an explant of the entire system.The patient has regained function in their legs and the pain has improved.Additional information was received that the patient's symptoms started immediately postoperatively.The physician assessed that the suspected cause of the neurological symptoms was due to the hematoma, and he feels it was also device and procedure related.The location of the hematoma was in the patients epidural space.The patient is doing well and has fully recovered.The explanted devices will not be returned as they were disposed at the hospital per protocol.

• Brand Name: COVEREDGE MRI
• 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: 20048991
• Report Number: 3006630150-2024-05543
• Device Sequence Number: 7955723
• Product Code: LGW
• UDI-Device Identifier: 08714729995814
• UDI-Public: 08714729995814
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/19/2025
• Device Model Number: SC-8436-50
• Device Catalogue Number: SC-8436-50
• Device Lot Number: 7083777
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 09/20/2023
• 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: 73 YR
• Patient Sex: Male