Issues with St Jude PM 2210

St Jude Medical PM 2210 implanted JUL 2013. I am age 57 now and in great health except for the PM side affects:

1) syncope - fainted on hard pavement this past Thursday.
2) electrical shock/pain/discomfort
3) chest pain around the PM
4) left arm pain
5) tingling fingers left hand
6) light-headed, dizzy, anxiety
7) fainting spells
8) shortness of breath, fatigue
When St Jude staff read the pacemaker, they hear background noise, but cannot or will not state what causes the noise.
My cardiologist stated that there is a loop in one of the leads, but makes no statement of cause and effect.

Please go to the FDA website and if you are having any issues, notify the FDA. I located several incident reports involving the St. Jude PM2210, but no recall because St. Jude is smart enough to "fix" the problem.

These are MALFUNCTION REPORTS, which can be found on the FDA website. Do a search for FDA Recalls. There are issues with the Pulse Generator and Leads.

If we all share information we might be able to save a life or at least improve our quality of life. I am lucky that when I fainted on the pavement that I didn't crack open my skull.

4 Comments

FDA Website

by djohnston - 2016-05-15 05:05:25

http://www.fda.gov/Safety/Recalls/default.htm

FDA Recall Search Database

by djohnston - 2016-05-15 05:05:41

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm

FDA Website Medical Devices

by djohnston - 2016-05-15 05:05:53

http://www.fda.gov/medicaldevices/safety/default.htm

PM SYNCOPE Research Analysis

by djohnston - 2016-05-15 08:05:36

http://www.stars.org.uk/files/file/Patient%20Day%20Presentations%202012/120923-Pacemakers%20&%20neurocardiogenic%20syncope,%20A%20Brandes.pdf

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Yesterday was my first day mountain biking after my implant. I wiped out several times and everything is fine. There are sports after pacemakers!