PRIMEADVANCED

Report

Report Number: 3007566237-2013-00302
Event Type: Injury
Date Received: January 28, 2013
Report Date: January 9, 2013
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. PRODUCT ID 3889, PRODUCT TYPE LEAD PRODUCT ID 37082, (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT HAD A SUSPECTED ALLERGIC REACTION. THE REPORTER STATED THAT THE PATIENT HAD A RASH OVER THE DEVICE POCKET AREA AND DOWN THE LEG. IT WAS REPORTED THAT THE DEVICE POCKET HAD STARTED TO ERODE. THE REPORTER STATED THAT THE PATIENT SAID SHE HAD A METAL ALLERGY. THE NEXT DAY, IT WAS REPORTED THAT MATERIAL SPECIFICATIONS WERE REQUESTED AND THE PATIENT'S DOCTOR WANTED TO DO TESTING. THE FOLLOWING DAY, IT WAS REPORTED THAT THE DEVICE AND EXTENSION WERE GOING TO BE REMOVED. TWO DAYS LATER, IT WAS REPORTED THAT THE DEVICE AND EXTENSION WERE REMOVED BUT THE LEADS WERE LEFT IN THE PATIENT AND CAPPED OFF WITH A CLOSED BOOT. THE REPORTER STATED THAT THE PLAN WAS TO DETERMINE IF THE PATIENT HAD AN ALLERGY. IT WAS NOTED THAT IF THE PATIENT DID HAVE AN ALLERGY, SHE WANTED TO GO ON IMMUNOSUPPRESSIVE MEDICATIONS SO THE DEVICE COULD BE REPLACED. AT THE TIME OF SURGERY, SAMPLES WERE SENT OFF TO DETERMINE IF THERE WAS AN INFECTION, ALTHOUGH IT APPEARED THERE WASN'T. IT WAS NOTED THAT THE PATIENT WAS GOING FOR ALLERGY TESTING ON (B)(6)-2013. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
38254	PRIMEADVANCED	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC NEUROMODULATION	37702

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention