MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION WAVEWRITER ALPHA PRIME 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1416

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Inadequate Pain Relief (2388); Implant Pain (4561)

Event Date 04/08/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: exact date unknown, event occurred six month ago from the date the manufacturer became aware of the event.

Event Description

It was reported that the patient was experiencing significant amount of pain at the pocket site.The patient had a lidocaine patch over the ipg site.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218700, model: sc-2218-70, serial: (b)(6), batch: (b)(6).

Event Description

It was reported that the patient was experiencing significant amount of pain at the pocket site.The patient had a lidocaine patch over the ipg site.Additional information was received that the patient was experiencing inadequate stimulation.The patient underwent a procedure wherein the ipg and leads were explanted.The explanted devices were not returned.

• Brand Name: WAVEWRITER ALPHA PRIME 16
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 15705288
• MDR Text Key: 302762026
• Report Number: 3006630150-2022-05879
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985068
• UDI-Public: 08714729985068
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/12/2023
• Device Model Number: SC-1416
• Device Catalogue Number: SC-1416
• Device Lot Number: 206765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 52 KG