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	Muscle Weakness/Atrophy (1967); Numbness (2415); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	03/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-ipg-r, upn: m365sc11600, model: sc-1160, serial: (b)(4), batch: 351172; product family: scs-ipg-r, upn: m365sc11320, model: sc-1132, serial: (b)(4), batch: 2000018909.
Event or Problem Description
It was reported that the patient was experiencing intense muscle spasms frequency and weakness on the legs, foot and hips.The patient underwent a procedure wherein spinal cord stimulator was removed.No further information could be obtained despite good faith efforts.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 14875650
• Report Number: 3006630150-2022-03199
• Device Sequence Number: 17441940
• Product Code: LGW
• UDI-Device Identifier: 08714729832683
• UDI-Public: 08714729832683
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted 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): 06/30/2022

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: 10/24/2018
• Device Model Number: SC-8352-50
• Device Catalogue Number: SC-8352-50
• Device Lot Number: 19866458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• 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 Age: 57 YR
• Patient Sex: Female