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

Model Number	429568
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore only based on the returned device data as well as the inspection of the quality documents associated with the manufacture of this particular device.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.In a next step, the returned device data was inspected.During the inspection the clinical observation could be confirmed.Analysis revealed that the eri battery status was activated during an automatic capacitor reformation on (b)(6) 2020, because the maximum charging time was exceeded.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.Biotronik has informed the health care professional about this analysis result, who decides, based on the patients individual circumstances and medical judgment, if the device will be exchanged.Should further relevant information or the device itself become available, this investigation will be updated and you will be informed accordingly.
Event or Problem Description
After an implantation period of approx.3 months, it was observed that the device shows the eri status.
Additional Manufacturer Narrative
Upon receipt, the device was interrogated confirming the battery status eri.Inspection of the returned device data as well as the memory content revealed that the eri battery status was activated during an automatic capacitor reformation on october 2nd, 2020, because the maximum charging time was exceeded.Therefore the device was opened to inspect the inner assembly and to check the functionality of the electronic module.The inspection revealed that one high voltage capacitor was damaged.This damage led to an elevated leakage current of that capacitor, causing a prolonged charge time as mentioned in the complaint description.In addition the manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.Particularly the final acceptance test proved the device functions to be as specified.In conclusion, the clinical observation resulted from a damaged high voltage capacitor.The manufacturing records document a normal device production.It is therefore assumed, that the damage occurred after the device shipment, however the date of occurrence was not determinable.

• Brand Name: INTICA NEO 5 DR-T DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 10996432
• Report Number: 1028232-2020-05470
• Device Sequence Number: 3562606
• Product Code: MRM
• UDI-Device Identifier: 04035479156947
• UDI-Public: 04035479156947
• Combination Product (Y/N): N
• PMA/510(K) Number: P000009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 429568
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/29/2021; 01/13/2022
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 02/01/2021; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown