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

Model Number SC-8216-70

Device Problem Migration (4003)

Patient Problems Unspecified Infection (1930); Implant Pain (4561)

Event Date 05/08/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown, event occurred six months ago from the date the manufacturer was made aware.

Event Description

It was reported that the patient developed a suspected infection at the pocket site.Symptom of pocket pain was noted.The patients lead had migrated and was confirmed via x-ray.

Event Description

It was reported that the patient developed a suspected infection at the pocket site.Symptom of pocket pain was noted.The patients lead had migrated and was confirmed via x-ray.Additional information was received that infection was confirmed and the patient underwent an explant procedure.It was unknown what cause the infection and unknown if patient was given medications.The patient was doing well postoperatively.The explanted devices were kept by facility.

Manufacturer Narrative

Additional suspect medical device component involved in the event: product family: scs-paddle leads, upn: m365sc8216700, model: sc-8216-70, serial: (b)(6), batch: (b)(6).

• 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: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15882701
• MDR Text Key: 304501523
• Report Number: 3006630150-2022-06619
• Device Sequence Number: 1
• Product Code: LGW
• 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,Followup
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/05/2022
• Device Model Number: SC-8216-70
• Device Catalogue Number: SC-8216-70
• Device Lot Number: 7071285
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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: 63 YR
• Patient Sex: Female