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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION PACEMAKER; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L311
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 02/27/2020
Event Type  Injury  
Event Description
After some incidents of arrhythmia, when medication did not help, the cardiologist recommended a pacemaker which was implanted on the above date.There had been no warning given to me about the fact that this pacemaker was an electronic device that would constantly radiate and could not be turned off.I am highly allergic to amf fields and had a bad reaction instantly.My allergy got worse and worse over time and i asked the cardiologist to turn the pacemaker off.That's when i found out that turning it off is impossible, the battery cannot be removed, the removal is only possible by an additional surgery, and no cardiologist i have consulted wants to perform the required surgery.There should have been a warning on the part of boston scientific alerting the doctor that the device is contraindicated for people with hypersensitivity to electro-magnetic waves.I have been suffering from all the symptoms of emf exposure, getting worse and worse, had the emf exposure been mentioned at the time before the implant, or the impossibility to shut it off, i would never have consented to the surgery.Boston scientific gave no warning.Now i cannot get rid of the device on my own and need help.
 
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Brand Name
PACEMAKER
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key12252164
MDR Text Key264481843
Report NumberMW5102852
Device Sequence Number1
Product Code LWP
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberL311
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient Weight82
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