MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SPECTRA WAVEWRITER, IMPLANTABLE PULSE GENERATOR KIT; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC235270

Patient Problem Unspecified Infection (1930)

Event Type  malfunction  

Event Description

Caller reported the patient (pt) had a device explanted in (b)(6) 2020 due to infected leads.Caller was unable to determine type of device or manufacturer.Caller stated operative report indicated removal of "4 occipital leads and pulse generator." caller provided information on 2 leads.The first lead is model sc1160, sn (b)(6).The second lead is model sc235270, sn (b)(6).Ref report: mw5151075."this report reflects information received by fda in the form of a notification per 803.22 (b)(2)".Refer to add'l documents in i2k.

• Brand Name: SPECTRA WAVEWRITER, IMPLANTABLE PULSE GENERATOR KIT
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 18650039
• MDR Text Key: 334781312
• Report Number: MW5151076
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SC235270
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2024
• Patient Sequence Number: 1