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

Model Number SC-8216-70

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/26/2018

Event Type  Injury  

Event Description

It was reported that the patient was not getting an adequate pain relief.The patient underwent a revision procedure wherein the paddle lead was repositioned and the physician added a new paddle lead.The patient was doing well postoperatively.

• 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: 12598966
• MDR Text Key: 275432197
• Report Number: 3006630150-2021-05649
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729779919
• UDI-Public: 08714729779919
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2020
• Device Model Number: SC-8216-70
• Device Catalogue Number: SC-8216-70
• Device Lot Number: 7006919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2018
• 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: 81 YR
• Patient Weight: 91