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

Model Number SC-8216-70

Device Problems Fracture (1260); Unexpected Therapeutic Results (1631); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/10/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced inadequate stimulation about a month and a half ago.Reprogramming was performed but was unsuccessful.The patients pain area changed from the lower back and left leg to the area below the last left ribs.The patient also experienced a burning sensation.The physician decided to take an x-ray and it revealed lead migration and damage to the structure of the lead.The patient underwent an explant procedure to replace the lead.During the procedure, every contact from the lead was separated and the cable from the lead was broken.The patient is doing well postoperatively and has fully recovered.

• 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: 13872918
• MDR Text Key: 287819202
• Report Number: 3006630150-2022-01196
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SC-8216-70
• Device Catalogue Number: SC-8216-70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2022
• Initial Date FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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