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	Erosion (1750); Discomfort (2330); Implant Pain (4561)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was experiencing pain and discomfort at the lead extension connection where the leads have come very close to the surface.The lead extensions did not break through the skin.The patient did not experience any weight changes.The physician assessed that the event was due to the way in which the patient scars following surgery.The patient underwent a revision procedure, and the physician chose to reposition the ipg to under the right arm and replace the two lead extensions.The ipg was repositioned due to patient preference, as she was finding it harder to reach around to her buttock to charge as she ages.The explanted lead extensions will not be returned, as they were not released by the hospital.The patient is doing well postoperatively and recovering well.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event.Brand name: null, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: 7075700.Brand name: precision spectra, upn: m365sc11320, model: sc-1132, serial: (b)(6), batch: 205511.
Event or Problem Description
It was reported that the patient was experiencing pain and discomfort at the lead extension connection where the leads have come very close to the surface.The lead extensions did not break through the skin.The patient did not experience any weight changes.The physician assessed that the event was due to the way in which the patient scars following surgery.The patient underwent a revision procedure, and the physician chose to reposition the ipg to under the right arm and replace the two lead extensions.The ipg was repositioned due to patient preference, as she was finding it harder to reach around to her buttock to charge as she ages.The explanted lead extensions will not be returned, as they were not released by the hospital.The patient is doing well postoperatively and recovering well.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event brand name: null, upn: m365sc3138350, model: sc-3138-35, serial: (b)(6), batch: (b)(6).Brand name: precision spectra, upn: m365sc11320, model: sc-1132, serial: (b)(6), batch: (b)(6).Correction to initial mdr in box d6b explant date.

• 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: 16837305
• Report Number: 3006630150-2023-02368
• Device Sequence Number: 15381483
• Product Code: LGW
• UDI-Device Identifier: 08714729760559
• UDI-Public: 08714729760559
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: 05/13/2023
• Device Model Number: SC-3138-35
• Device Catalogue Number: SC-3138-35
• Device Lot Number: 7074716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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