MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 540 DR-T; ICD

Model Number 360346

Device Problem Programming Issue (3014)

Patient Problem Tachycardia (2095)

Event Date 10/23/2016

Event Type  Injury  

Event Description

Ous mdr - it was reported that approximately 65 months after the implantation the patient was admitted to emergency room with a pacing rate 150 in atrium and ventricle.The problem was resolved through device reprogramming.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process which might be related to the clinical observation.The returned device data have been analyzed.A paced rhythm at the upper tracking rate that was programmed to 150 bpm was confirmed on the screenshot available for analysis.Furthermore an av- delay significantly shorter than 200 ms was noted.In a next step a similar demo device was bench tested in the laboratory and exhaustive attempts to reproduce the failure condition were undertaken.Under normal and expected operating conditions it was not possible to reproduce the clinical observation.However, due to the observed shortened av delay below the programmed parameters, an inconsistent memory content was deliberately introduced in the memory area storing the executed av-delay in the laboratory.In combination with the programmed parameters, particularly upper tracking interval, the post ventricular atrial refractory period, a rate at the maximum sensor rate and a certain sequence of sensed events in both channels, the device delivered a pacing sequence that matched the clinical observation, limited by the programmed upper tracking rate.In conclusion, a definite root cause determination was not possible.Under normal device operation the failure condition was not reproducible despite exhaustive attempts.Only after deliberate introduction of an inconsistent memory content in the laboratory, the device behavior was reproducible under certain constraints.Due to the reproducibility of the clinical observation it is reasonable to assume that the root cause is an inconsistent memory content in the memory area of the executed av delay in combination with the programmed therapy parameters as well as intrinsic rhythm (av-delay, msr, utr, pvarp, etc.).Based on the reproducibility a repetition of the clinical event is highly unlikely, however, cannot be excluded as a definite root cause determination was not possible based on the available data.

• Brand Name: LUMAX 540 DR-T
• Type of Device: ICD
• 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: 6120863
• MDR Text Key: 60684576
• Report Number: 1028232-2016-04671
• Device Sequence Number: 1
• Product Code: MRM
• 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
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 360346
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2011
• 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; Required Intervention