MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 5 DR-T PROMRI DF-1; ICD

Model Number 390114

Device Problem Failure to Interrogate (1332)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

It was reported that this device could not be interrogated.Device was explanted and replaced.

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 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 final acceptance test proved the icd functions to be as specified.The returned follow-up data from (b)(6) 2020 have been analyzed.The analysis did not show any anomalies.The battery status was mos1 with 3.09v and the current consumption of the icd was normal.No anomalies were observed.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.Based on the information available for analysis no conclusions can be drawn regarding the root cause of the clinical observation.An analysis of the icd itself would be necessary.Should the icd become available for analysis, this investigation will be updated.

Manufacturer Narrative

Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Next, the icd was subjected to an electrical analysis, revealing that the device could not be interrogated.Therefore, the device was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage showed a depleted battery.The electronic module was attached to an external power supply to test the functionality of the module.Thereby, the electrical parameters, particularly the current consumption of the electronic module were found to be normal and as expected.The ability of the electronic module to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.The battery was sent to the manufacturer for a thorough analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process, associated with this battery.The battery was subjected to a visual inspection which did not reveal any signs of damage.In a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified lithium plating, which led to an elevated internal self-depletion and, as a result, to the clinical observation.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.

• Brand Name: ILESTO 5 DR-T PROMRI DF-1
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10576864
• MDR Text Key: 208293970
• Report Number: 1028232-2020-04060
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: 390114
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization