FDA Adverse Event Other Summary report: N

ST. JUDE

MDR report key: 2412174 · Received January 8, 2012

Report

Report Number
MW5023769
Event Type
Other
Date Received
January 8, 2012
Date of Event
October 17, 2009
Report Date
January 8, 2012
Manufacturer
ST. JUDE
Product Code
DXY
Report Source
Voluntary report
Reporter Location
OH, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I HAVE A ST. JUDE PACEMAKER, I HAVE BEEN REPORTING TO MY DOCTOR THAT IT IS RECEIVING ELECTRONIC SIGNALS, AND THAT IT MAKES NOISES AS IF IT'S A CELL PHONE ON VIBRATE. I HAVE HAD SEVERAL PACEMAKER TESTS, AND THEY SAY IT'S OK. I AM WORRIED THAT SOMETHING IS TERRIBLY WRONG WITH THE PACEMAKER EVEN THOUGH THEY SAY ITS OK. I CAN HEAR CB, ACTIVE, CELL PHONES, AND OTHER NOISES COMING FROM MY LEFT CHEST WALL, AND NO ONE CAN SAY THAT'S OK. IT NEVER HAPPENS WHEN I AM TESTED. I WOULD LIKE TO KNOW IF THIS PACEMAKER HAS BEEN RECALLED, OR HAS SOME TYPE OF DEFECT. IT WAS ON PLACED IN (B)(6) 2008. DATES OF USE: (B)(6) 2008 - (B)(6) 2012. REASON FOR USE: DOCTOR ACCIDENTLY PIERCED PT'S HEART.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 ST. JUDE ST. JUDE PACEMAKER DXY ST. JUDE

Patients

Seq Age Sex Outcome Treatment
1 56 YR Other