FDA Adverse Event Injury Summary report: N

SPECTRA WAVEWRITER

MDR report key: 14136679 · Received April 18, 2022

Report

Report Number: 3006630150-2022-01677
Event Type: Injury
Date Received: April 18, 2022
Date of Event: March 23, 2022
Report Date: April 18, 2022
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
UDI-DI: 08714729951254
PMA / PMN Number: P030017
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: (B)(4). PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: UNK-M-SC-2366-50, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: (B)(4).

Description of Event or Problem · 0

IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND DIFFICULTY CHARGING THE IPG. ELECTRO-OPTICAL SYSTEM EOS IMAGING DISPLAYED THAT THE IMPLANTABLE PULSE GENERATOR FLIPPED IN THE POCKET AND THE LEADS MIGRATED. DEVICE REPROGRAMMING WAS ATTEMPTED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPOSITIONED IN THE POCKET AND FOUR LEADS WERE REPLACED PER THE PHYSICIANS PREFERENCE. THE PATIENT IS DOING WELL POSTOPERATIVELY. THE IPG REMAINS IMPLANTED IN THE PATIENT AND THE REPLACED LEADS WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
658944	SPECTRA WAVEWRITER	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1160	361964	08714729951254

Patients

Seq	Age	Sex	Outcome	Treatment
1		Female	Required Intervention