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

Model Number BOSTON SCIENTIFIC SPECTRA WAVEWRITER IPG

Device Problem Output Problem (3005)

Patient Problems Granuloma (1876); Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that the patient was implanted with a medtronic paddle lead and boston scientific ins.The patient had a large granuloma growth outside the paddle placement incision.Upon explantation, the granuloma was also found growing along the dura.After removing the granuloma, they explanted the boston scientific ins and discovered an infection in the stimulator pocket.The granuloma appears to have been completely removed yesterday along with the medtronic paddle lead and boston scientific ins.There were no plans to reimplant anything.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BOSTON SCIENTIFIC INS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17536022
• MDR Text Key: 321047043
• Report Number: MW5142914
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: BOSTON SCIENTIFIC SPECTRA WAVEWRITER IPG
• Patient Sequence Number: 1