MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 300 VR-T; ICD

Model Number 355270

Device Problem Difficult to Interrogate (1331)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 12/12/2013

Event Type  malfunction  

Event Description

Ous mdr - after an implantation time of about 16 months, it was reported that the icd was difficult to interrogate during the follow-up on (b)(6) 2013.The patient also reported that he had received a shock 8 days before that.Support by radiology findings, a lead fracture in the costa-clavicular region is suspected.

Manufacturer Narrative

The analysis of the icd showed that the icd was damaged due to a shock delivery into an external low-ohmic shock path.A sparkover occurred between the high-voltage conductors of the lead during the shock delivery.This conclusion can be drawn both from the damage manifestation of the damaged final shock stage of the icd and from the sparkover traces on the inner conductor helix 23 cm distal of the is-1 connector pin.There were no indications of material defects or manufacturing errors for either the icd or the lead.

• Brand Name: LUMAX 300 VR-T
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-12 359; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 3723769
• MDR Text Key: 4277472
• Report Number: 1028232-2014-01080
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 355270
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization