MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 HF-T; CRT-D

Model Number 360347

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problems Ventricular Fibrillation (2130); Patient Problem/Medical Problem (2688)

Event Date 01/22/2017

Event Type  malfunction  

Event Description

Ous mdr.It was reported that this patient was found unconscious due to ventricular fibrillation, by the er doctor.The patient was externally defibrillated and was admitted to the hospital.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the existing production documents and the returned device data.The returned device data were thoroughly analyzed and did not show any anomalies that could be related to the clinical observation.The device memory did not contain any episodes, therefore the sensed signals could not be evaluated.Overall, there were no indications of a dysfunction of the implant.In addition, the manufacturing process of this device was reviewed.The production documents did not show any anomalies that could be related to the complaint.All manufacturing steps had been carried out correctly.

• Brand Name: LUMAX 540 HF-T
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 6305869
• MDR Text Key: 66660293
• Report Number: 1028232-2017-00309
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 360347
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• 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