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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMPULSE DYNAMICS USA INC CCM DEVICE; IMPLANTABLE PULSE GENERATOR

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IMPULSE DYNAMICS USA INC CCM DEVICE; IMPLANTABLE PULSE GENERATOR Back to Search Results
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
¿programming changes made to impulse dynamics [cardiac contractility modulation] ccm device due to crosstalk¿.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
CCM DEVICE
Type of Device
IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
IMPULSE DYNAMICS USA INC
MDR Report Key18875413
MDR Text Key337471644
Report NumberMW5152554
Device Sequence Number1
Product Code QFV
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/07/2024
Patient Sequence Number1
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