SPECTRA WAVEWRITER

Report

Report Number: 3006630150-2021-03862
Event Type: Injury
Date Received: July 19, 2021
Date of Event: March 20, 2021
Report Date: October 27, 2021
Manufacturer: BOSTON SCIENTIFIC NEUROMODULATION
Product Code: LGW
UDI-DI: 08714729951254
PMA / PMN Number: P030017
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PHYSICIAN

Narratives

Description of Event or Problem · 0

IT WAS REPORTED THAT PATIENTS IPG INCISION SITE DID NOT HEAL PROPERLY. IT WAS ALSO REPORTED THAT THE IPG WAS NOT PLACED DEEP ENOUGH CAUSING MORE PAIN IN CERTAIN POSITIONS. AN X-RAY WAS TAKEN AND REVEALED THAT THE IPG AND LEADS HAD MIGRATED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE IPG REMAIN IMPLANTED IN THE PATIENT.

Additional Manufacturer Narrative · 1

EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7073076. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(4), BATCH: 7083342.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENTS IPG INCISION SITE DID NOT HEAL PROPERLY. IT WAS ALSO REPORTED THAT THE IPG WAS NOT PLACED DEEP ENOUGH CAUSING MORE PAIN IN CERTAIN POSITIONS. AN X-RAY WAS TAKEN AND REVEALED THAT THE IPG AND LEADS HAD MIGRATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1086053	SPECTRA WAVEWRITER	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	BOSTON SCIENTIFIC NEUROMODULATION	SC-1160	367170	08714729951254

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR		Required Intervention