FDA Adverse Event Injury Summary report: N

ATTAIN STARFIX

MDR report key: 2781664 · Received October 10, 2012

Report

Report Number: 2649622-2012-12879
Event Type: Injury
Date Received: October 10, 2012
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: OJX
PMA / PMN Number: P060039
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE PATIENT INDICATES THAT LEAD HAS BEEN "TUNED" SO THAT IT DOES NOT HAPPEN. THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT DOES NOT GET HEART RATE UP ENOUGH WITH NORMAL WALKING ACTIVITIES. THE DEVICE WAS REPROGRAMMED AND REMAINS IN USE. IT WAS FURTHER REPORTED BY THE PATIENT THAT THEY THOUGHT THEIR LEFT VENTRICLE HAD BEEN OVER PACED FOR YEARS WHICH DAMAGED THE VENTRICLE AND THE PATIENT'S EJECTION FRACTION. THE PATIENT ALSO REPORTED THAT SINCE THE DEVICE WAS REPROGRAMMED THEY HAD FELT BETTER, BUT IT HAD BEEN "DE-TUNED" AND THE PATIENT IS NOW EXPERIENCING "VISION DISTURBANCES", "EYE ACHES" AND "PRESSURE" IN HEAD. THE DEVICE REMAINS IN USE. THE PATIENT LATER REPORTED THAT THE DEVICE WAS SET TOO HIGH AND THE PATIENT WAS OVER PACED FOR A PERIOD OF TIME, BUT THE DEVICE IS NOW SO LOW THAT THE PATIENT CAN "HARDLY FUNCTION". THE PATIENT ALSO STATED THAT ONE OF THE LEADS WAS IN THE WRONG PLACE AND STIMULATES THE PATIENT'S DIAPHRAGM.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATTAIN STARFIX	IMPLANTABLE PACING LEAD	OJX	MEDTRONIC PUERTO RICO, INC.	4195

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention	6947 IMPLANTABLE TACHY LEAD