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 Wound Dehiscence (1154); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 07/30/2022

Event Type  Injury  

Event Description

It was reported that the patient had a suspected infection and the pocket incision site had opened exposing the battery.Symptom of drainage was noted at the battery site.The physician believed the infection was not device related.The patient underwent an explant procedure.

Manufacturer Narrative

Exact date unknown, event occurred a couple of days from the date the manufacturer became aware of the event.Additional suspect medical device component involved in the event: product family: scs-paddle leads-mri; upn: m365sc8436500; model: sc-8436-50; serial: (b)(4); batch: (b)(4).

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15280208
• MDR Text Key: 298455737
• Report Number: 3006630150-2022-04236
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985099
• UDI-Public: 08714729985099
• 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
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 542932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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: 85 YR
• Patient Sex: Male