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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 340 VR-T ICD

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BIOTRONIK SE & CO. KG LUMAX 340 VR-T ICD Back to Search Results
Model Number 355271
Device Problems Explanted; Overheating of device or device component
Event Date 05/12/2010
Event Type  Malfunction  
Manufacturer Narrative

Event Description

Ous mdr -it was reported that after one month of being implanted, a loud pop sound was audible from this icd while implanted and in service, followed by a burn injury of the pt's chest. The device has been explanted and returned to the mfr in (b)(4) for analysis.

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Brand NameLUMAX 340 VR-T
Type of DeviceICD
Manufacturer (Section D)
Manufacturer (Section G)
Manufacturer Contact
6024 jean road
lake oswego , OR 97035
(800) 800 -8005
80054703 8005470394
MDR Report Key1708285
Report Number1028232-2010-01289
Device Sequence Number1
Product CodeLWS
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 05/19/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number355271
Device Catalogue Number355271
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Date Manufacturer Received05/19/2010
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 05/28/2010 Patient Sequence Number: 1