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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KGLUMAX 340 VR-TICD

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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   Patient Outcome  Hospitalization
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 F)
BIOTRONIK SE & CO. KG
berlin
GERMANY
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
berlin
GERMANY
Manufacturer (Section G)
BIOTRONIK SE & CO. KG
berlin
GERMANY
Manufacturer Contact
6024 jean road
lake oswego , OR 97035
(800) 547 -0394
Device Event Key1758259
MDR Report Key1708285
Event Key1622196
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
Was The Report Sent To Manufacturer? 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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

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