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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI S DX 65/15; ICD LEAD
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BIOTRONIK SE & CO. KG PLEXA PROMRI S DX 65/15; ICD LEAD Back to Search Results
Model Number 436909
Device Problems Fracture (1260); Impedance Problem (2950); Unstable Capture Threshold (3269)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/16/2024
Event Type  malfunction  
Event Description
Lead was capped due to possible fracture increasing threshold and impedance.No adverse patient events were reported.Should additional information be received, this file will be update.
 
Manufacturer Narrative
The lead 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.
 
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Brand Name
PLEXA PROMRI S DX 65/15
Type of Device
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key19177356
MDR Text Key341026370
Report Number1028232-2024-02274
Device Sequence Number1
Product Code NVY
UDI-Device Identifier04035479158781
UDI-Public(01)04035479158781(17)221130
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number436909
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 Manufactured11/17/2020
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;
Patient Age54 YR
Patient SexFemale
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