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 |