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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Impaired Healing (2378)

Event Date 08/16/2021

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-paddle leads, upn: m365sc8120500, model: sc-8120-50, serial: (b)(4), batch: 166282a.

Event Description

It was reported that the patient experienced two non-device related falls and poor wound healing at the implantable pulse generator (ipg) incision site within 10 days of having undergone an ipg replacement procedure.The patient was sent to wound care and placed on antibiotics; however, approximately 3 weeks post-revision procedure, the patient passed away due to the reported infection.The physician assessed the infection had traveled along the leads, causing the infection to spread, leading to the patient's passing.

Event Description

It was reported that the patient experienced two non-device related falls and poor wound healing at the implantable pulse generator (ipg) incision site within 10 days of having undergone an ipg replacement procedure (mfr.Report 3006630150-2021-04842).The patient was sent to wound care and placed on antibiotics; however, approximately 3 weeks post-revision procedure, the patient passed away due to the reported infection.The physician assessed the infection had traveled along the leads, causing the infection to spread, leading to the patient's passing.

Manufacturer Narrative

Correction to the initial mdr in block b5.

• 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
• MDR Report Key: 12443816
• MDR Text Key: 270478943
• Report Number: 3006630150-2021-05041
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985068
• UDI-Public: 08714729985068
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: SC-1416
• Device Catalogue Number: SC-1416
• Device Lot Number: 203296
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 71 YR