MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION WaveWriter Alpha? Prime; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-1432
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Sepsis (2067)
Date of Event	09/01/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported that a spinal cord stimulation (scs) patient following the implantable pulse generator (ipg), patient began experiencing recurrent and progressively worsening discomfort, pain, and complications at or associated with the site of the ipg.A large mass developed at the location of the ipg and treating physician expressed that the patient was getting infections from the stimulator and that the infections were getting worse.Despite medical intervention, the infections and complications persisted and escalated in severity.Later on, patient presented again with physician with ongoing back and leg pain and a request for stimulator removal due to it becoming infective; lack of any relief; and pain, particularly at the site of the battery.Due this request, physician performed the explant of the entire system.After the explant, patient continued to experience fever, back pain, and weakness consistent with ongoing spinal infection.This infection progressed to life-threatening multilevel spinal infections and systemic sepsis.Specifically, imaging and clinical findings revealed: t7-t11 and right t2 epidural abscess/phlegmon; t12-l2 discitis/osteomyelitis with associated abscesses; c4-6 discitis/osteomyelitis with prevertebral abscess; bilateral psoas abscesses; mssa bacteremia; and septic emboli to the brain.Later, patient was hospitalized was treated for severe sepsis, mssa bacteremia, multilevel spinal osteomyelitis/discitis with epidural abscesses and phlegmon, bilateral psoas abscesses, acute encephalopathy, and related complications.During this approximately 16-day hospitalization, she required intensive care, was placed on mechanical ventilation (including following a pea cardiac arrest), and received aggressive intravenous antibiotic therapy (including agents such as zosyn, ancef, and others directed at mssa).Bilateral psoas abscesses were aspirated under ct guidance, yielding purulent fluid positive for mssa.Despite these aggressive measures, the sepsis and multilevel infections could not be controlled.Neurosurgery determined she was a poor surgical candidate for operative drainage of the epidural abscesses given her overall frailty and high surgical risk.Some days after the hospitalization, patient died as a direct and proximate result of sepsis and the multilevel spinal infections and complications.
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model number/catalog number: sc-8336-50.Serial number: (b)(6).Batch/lot number: 7077220.Model/catalog description: coveredge 32 surgical lead kit 50 cm.Unique identifier (udi) #: (b)(4).Model number/catalog number: sc-4316.Serial number: na.Batch/lot number: 28504930.Model/catalog description: clik anchor.Unique identifier (udi) #: (b)(4).

• Brand Name: WaveWriter Alpha? Prime
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: ricardo amaro castro ; 25155 rye canyon loop; valencia, CA 91355 ; +1(320)800-7570
• MDR Report Key: 50876059
• Report Number: 3006630150-2026-07041
• Device Sequence Number: 10674739
• Product Code: LGW
• UDI-Device Identifier: 08714729985075
• UDI-Public: (01)08714729985075(17)231029(10)207144
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/29/2023
• Device Model Number: SC-1432
• Device Catalogue Number: SC-1432
• Device Lot Number: 207144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 10/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death; Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female