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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG DEXTRUS 53 MODEL 4136 US 644136-102; PACING LEAD

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BIOTRONIK SE & CO. KG DEXTRUS 53 MODEL 4136 US 644136-102; PACING LEAD Back to Search Results
Model Number 358754
Device Problems Pacing Intermittently (1443); Ambient Noise Problem (2877)
Patient Problems Dizziness (2194); Syncope/Fainting (4411)
Event Date 02/20/2024
Event Type  Injury  
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.
 
Event Description
Boston scientific provided the following information: on (b)(6) 2024 simultaneous non-physiologic noise was seen on both a & v leads.The patient was contacted and reported dizziness and syncope.On (b)(6) at in-person visit, arm movements reproduced noise and inhibited pacing in both leads.Patient was admitted to the hospital.On (b)(6) a new system implanted on the right and the old system on left was turned off and abandoned.This lead was capped.Should additional information be received, this file will be updated.
 
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Brand Name
DEXTRUS 53 MODEL 4136 US 644136-102
Type of Device
PACING 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 Key18887702
MDR Text Key337461975
Report Number1028232-2024-01377
Device Sequence Number1
Product Code NVN
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 Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2018
Device Model Number358754
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2016
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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