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 Bacterial Infection (1735); Fever (1858); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067)

Event Date 05/04/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced an infection and therefore, underwent a spinal cord stimulator system explant procedure.The infection has improved postoperatively.The devices were not returned by the medical facility.Additional information regarding the infection has been unable to be obtained despite good faith efforts.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads-mri; upn: m365sc2408740; model: sc-2408-74 (4); serial: (b)(4); lot: 5123426, 5031582, 7073974, 7073975.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads-mri, upn: m365sc2408740, model: sc-2408-74 (4), serial: (b)(6), lot: 5123426, 5031582, 7073974, 7073975.

Event Description

It was reported that the patient experienced an infection and therefore, underwent a spinal cord stimulator system explant procedure.The infection has improved postoperatively.The devices were not returned by the medical facility.Additional information regarding the infection has been unable to be obtained despite good faith efforts.Additional information was received that the infection was located at the ipg and lead site.The symptoms of the methicillin-resistant staphylococcus aureus (mrsa) infection were fever, redness, hypotension and sepsis.The patient was also administered antibiotics.The infection was suspected to be device related.

• 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: 15193383
• MDR Text Key: 297539686
• Report Number: 3006630150-2022-03928
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729985099
• UDI-Public: 08714729985099
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/16/2023
• Device Model Number: SC-1232
• Device Catalogue Number: SC-1232
• Device Lot Number: 528615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female