MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 740 DR-T; ICD

Model Number 365606

Device Problem Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2018

Event Type  malfunction  

Event Description

Ous mdr - home monitoring alert was received that device detection has been off since (b)(6) 2018.During the last follow up the renamic shut down suddenly.The hospital has requested an analysis of the relationship between the renamic shutting down and the detection setting of the icd turning off.

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 returned device data have been analyzed.The clinical observation was not confirmed based on all available data.In particular the analysis showed that during the follow-up on january 10, 2018 at 09:59 and 10:05 the icd therapy was activated.The root cause for the clinical observation was therefore not determinable based on the data available for an analysis.For further insights a ram dump would be essential.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.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed no indication of a device malfunction, particularly the icd therapy was activated.However, for further insights a ram dump would be necessary.

Manufacturer Narrative

4/23/18 - we received an updated analysis.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 returned device data have been thoroughly analyzed.The analysis showed that during the follow-ups on january 10, 2018 at 09:59 and 10:05 the icd therapy was active.The programmer files documented a programmer shutdown at 10:06.However, further data inspection indicated that a restart of the programmer and therefore a renewal of the aborted rf session was initiated at 10:09.At this time the icd therapy was still active.Based on the icds memory data analysis the icd therapy was manually deactivated at 10:10 during the renewal of the rf connection.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.In conclusion, the device was not returned for analysis.The review of the quality documents confirmed a regular device manufacturing.The analysis of the returned device data revealed that the icd therapy was manually deactivated.No device malfunction was noted based on all available data.

• Brand Name: LUMAX 740 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: 7246896
• MDR Text Key: 99199870
• Report Number: 1028232-2018-00342
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365606
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2012
• 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