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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EDORA 8 DR-T; PACEMAKER

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BIOTRONIK SE & CO. KG EDORA 8 DR-T; PACEMAKER Back to Search Results
Model Number 407145
Device Problem Impedance Problem (2950)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2024
Event Type  malfunction  
Event Description
It was reported that the pacing impedance was too high a few hours after implantation.The pacemaker was replaced.No adverse patient events were reported.Should additional information be received, this file will be update.
 
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Brand Name
EDORA 8 DR-T
Type of Device
PACEMAKER
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
DE  12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key18727392
MDR Text Key335708484
Report Number1028232-2024-00920
Device Sequence Number1
Product Code NVZ
Combination Product (y/n)N
Reporter Country CodeDE
PMA/PMN Number
P950037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/16/2024
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
Device Operator Health Professional
Device Model Number407145
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/16/2024
Initial Date FDA Received02/16/2024
Date Device Manufactured11/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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