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

Model Number SC-8216-50

Device Problems Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problems Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)

Event Date 06/06/2022

Event Type  Injury  

Event Description

It was reported that the patient was experiencing inadequate stimulation as well as non-target stimulation in the ribs or stomach area due to lead migration.This was confirmed through an imaging.The patient underwent a lead replacement procedure and was doing well post-operatively.The explanted lead will not be returned.

Manufacturer Narrative

Event date: approximated based on the date the manufacturer became aware of the event.

• Brand Name: ARTISAN
• Type of Device: 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15588844
• MDR Text Key: 301587069
• Report Number: 3006630150-2022-05480
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729779902
• UDI-Public: 08714729779902
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/16/2023
• Device Model Number: SC-8216-50
• Device Catalogue Number: SC-8216-50
• Device Lot Number: 7073693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female