STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Report

• Report Number: MW5141550
• Event Type: Malfunction
• Date Received: August 12, 2023
• Report Date: October 1, 2010
• Manufacturer: MEDTRONIC
• Product Code: LGW
• Report Source: Voluntary report
• Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 0

BOSTON SCIENTIFIC NEUROMODULATION (BSN) RECEIVED INFORMATION ABOUT AN EVENT THAT WOULD HAVE BEEN REPORTABLE UNDER 21 CFR 803, MEDICAL DEVICE REPORTING WITHIN OUR COMPLAINT SYSTEM. HOWEVER, THE EVENT REPORTED WAS RELATED TO THE IMPLANTED SPINAL CORD STIMULATOR MANUFACTURED BY MEDTRONIC. ON SEPTEMBER 24, 2010, BSN BECAME AWARE THAT A PATIENT'S MEDTRONIC IPG IS GOING TO BE EXPLANTED AND REPLACED WITH A BSN PRECISION SYSTEM. THE REASON FOR THE MEDTRONIC IPG EXPLANT IS THAT IT'S MALFUNCTIONING. N/A THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
941433	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown

Terms

Patient problem · 1

• No Clinical Signs, Symptoms or Conditions

Product problems · 1

• Break

Type of report · 1

• Initial submission