FDA Adverse Event Injury Summary report: N

SPECTRA WAVEWRITER?

MDR report key: 24894511 · Received April 16, 2026

Report

Report Number: 3006630150-2026-02378
Event Type: Injury
Date Received: April 16, 2026
Date of Event: January 13, 2026
Report Date: May 26, 2026
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
Product Code: LGW
UDI-DI: 08714729951254
PMA / PMN Number: P030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 5139163 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2218-70 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7074323 MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 70 CM UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2352-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7071267 MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM UNIQUE IDENTIFIER (UDI)#: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-2352-50 SERIAL NUMBER: (B)(6) BATCH/LOT NUMBER: 7071564 MODEL/CATALOG DESCRIPTION: LINEAR 3-4 LEAD 50 CM UNIQUE IDENTIFIER (UDI)#: (B)(4).

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING PAIN RELIEF. THE PATIENT UNDERWENT A PROCEDURE WHEREIN THE IPG AND LEADS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY AND THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
517210	SPECTRA WAVEWRITER?	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	BOSTON SCIENTIFIC NEUROMODULATION CORPORATION	SC-1160	372142	08714729951254

Patients

Seq	Age	Sex	Outcome	Treatment
1