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

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.

• Brand Name: LUMAX 340 VR-T
• Type of Device: ICD
• 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 Key: 1758259
• MDR Report Key: 1708285
• Event Key: 1622196
• Report Number: 1028232-2010-01289
• Device Sequence Number: 1
• Product Code: LWS
• 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 Received: 05/28/2010
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device MODEL Number: 355271
• Device Catalogue Number: 355271
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 05/19/2010
• 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