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

Model Number SC-1216

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

Patient Problems Bacterial Infection (1735); Fever (1858)

Event Date 07/10/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.

Event Description

It was reported that the patient had methicillin-resistant staphylococcus aureus (mrsa) infection in the surgical sites.Symptom of fever was noted.The patient underwent an explant procedure.

Event Description

It was reported that the patient had methicillin-resistant staphylococcus aureus (mrsa) infection in the surgical sites.Symptom of fever was noted.The patient underwent an explant procedure.Additional information was received that the patient had an infection at the ipg site.The patient was placed on antibiotics and underwent an explant procedure.The patient was doing well postoperatively.The explanted device will not be returned.

• Brand Name: WAVEWRITER ALPHA 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: 12295283
• MDR Text Key: 265631239
• Report Number: 3006630150-2021-04362
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985082
• UDI-Public: 08714729985082
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/13/2023
• Device Model Number: SC-1216
• Device Catalogue Number: SC-1216
• Device Lot Number: 509220
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR