MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 340 HF-T; CRT-D

Model Number 355263

Device Problems Failure to Interrogate (1332); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Loss of consciousness (2418); Shock from Patient Lead(s) (3162)

Event Date 08/08/2016

Event Type  malfunction  

Event Description

Ous mdr - after an implantation time of 30 months, a shock delivery was reported.A subsequent interrogation of the device was no longer possible.The device was explanted and returned to biotronik.During the revision, damage was observed in the distal region of the right-ventricular lead.No further information is available regarding the connected leads.Aside from the shock delivery, which was followed by loss of consciousness, no deterioration of the patientstate of health was reported.

Manufacturer Narrative

After its receipt, the icd was first inspected visually.In the process, the sparkover traces were detected on the icd housing.The dot-shaped spots of melted titanium indicate a sparkover during the shock delivery between the housing and the df-1 rv conductor of the lead.In agreement with the clinical observation, it was not possible to interrogate the icd.For that reason, the icd housing was opened in the next step, and the inner structure was examined.During the inspection of the electrical module, damage to the final shock stages could be determined.This damage indicates a shock delivery into an external low-ohmic shock path, matching the sparkover traces on the icd housing.The damage to the module subsequently led to a permanently increased current uptake and then to a discharge of the battery.Due to the discharged battery, the icd could no longer be interrogated.The manufacturing process of this device was reviewed.The production documents did not show any anomalies that could be connected to the complaint.All manufacturing steps had been carried out correctly.In summary, the analysis of the icd showed damage to the final shock stages due to a shock delivery into an external low-ohmic shock path.This is consistent with the insulation damage of the icd lead described in the clinical observation.There was no material defect or manufacturing error.If any additional relevant information on the lead or the lead itself should become available, please send this to us also.The incident will then be updated accordingly.

• Brand Name: LUMAX 340 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: 5959918
• MDR Text Key: 55033427
• Report Number: 1028232-2016-03233
• 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: 08/16/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 355263
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2012
• 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