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

Model Number	SC-3138-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Discomfort (2330)
Date of Event	11/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a trial procedure, a clinical study patient experienced discomfort and went to the hospital due to suppuration of her surgical wound.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, serial #: (b)(4), batch: 7978872; product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, serial #: (b)(4), batch: 7079646; product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, serial #: (b)(4), batch: 7079578.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, batch/ serial #: (b)(6).Product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, batch/ serial #: (b)(6).Product family: scs-extension, upn: m365sc3138350, model: sc-3138-35, batch/ serial #: (b)(6).
Event or Problem Description
It was reported that during a trial procedure, a clinical study (a4105 inspire) patient experienced discomfort and went to the hospital due to suppuration of her surgical wound.Additional information was received that the previously reported event of the patient going to the hospital due to suppuration of her surgical wound did not occur.The patient experienced discomfort during the trial procedure, which the physician assessed as a regular uncomfortableness of the trial procedure.As there is no reportable allegation against the device itself and there was no serious injury, boston scientific no longer considers this to be a reportable event.

• Brand Name: NA
• 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: 16560477
• Report Number: 3006630150-2023-01318
• Device Sequence Number: 5690950
• Product Code: LGW
• UDI-Device Identifier: 08714729760559
• UDI-Public: 08714729760559
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2023

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: 09/24/2024
• Device Model Number: SC-3138-35
• Device Catalogue Number: SC-3138-35
• Device Lot Number: 7079668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 03/16/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2022
• 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: Other
• Patient Age: 39 YR
• Patient Sex: Female