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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNKNOWN PERMANENT PACEMAKER ELECTRODE
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UNKNOWN PERMANENT PACEMAKER ELECTRODE Back to Search Results
Model Number UNKNOWN - CS LEAD EPICARDAL LEAD
Device Problem Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Event Description
Device pocket infection (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
PERMANENT PACEMAKER ELECTRODE
Type of Device
PERMANENT PACEMAKER ELECTRODE
Manufacturer (Section D)
UNKNOWN
MDR Report Key17535995
MDR Text Key321159252
Report NumberMW5142887
Device Sequence Number1
Product Code DTB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 03/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Model NumberUNKNOWN - CS LEAD EPICARDAL LEAD
Patient Sequence Number1
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