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

Model Number SC-1232

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 04/22/2021

Event Type  Injury  

Event Description

It was reported that the patient had a clear fluid oozing from the ipg site.The patient underwent a revision procedure wherein the pocket site was re-stitched to prevent infection.

Event Description

It was reported that the patient had a clear fluid oozing from the ipg site.The patient underwent a revision procedure wherein the pocket site was re-stitched to prevent infection.Additional information was received that the patient had an infection at the ipg site.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted device will not be returned as it was kept by the medical facility.

• Brand Name: WAVEWRITER ALPHA
• 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: 12351860
• MDR Text Key: 267626406
• Report Number: 3006630150-2021-04685
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985099
• UDI-Public: 08714729985099
• 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: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/29/2023
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 508186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR