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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI S 65; ICD LEAD
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BIOTRONIK SE & CO. KG PLEXA PROMRI S 65; ICD LEAD Back to Search Results
Model Number 402266
Device Problems Fracture (1260); High impedance (1291)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2024
Event Type  malfunction  
Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
Event Description
A lead fracture was observed on an x-ray.Due to this fracture it was reported that the shock impedance was too high.The lead is still implanted with pacing function but without defibrillation function.The patient does not need it for the moment.Should additional information be received, this file will be updated.
 
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Brand Name
PLEXA PROMRI S 65
Type of Device
ICD LEAD
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 Key19210039
MDR Text Key341379943
Report Number1028232-2024-02375
Device Sequence Number1
Product Code NVY
Combination Product (y/n)N
Reporter Country CodeDE
PMA/PMN Number
P980023
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 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Model Number402266
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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