MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 3 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number	429571
Medical Device Problem Code	Delayed Charge Time (2586)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.27 months, it was observed that the charging time was too long.The icd was explanted.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for approximately 26 months and four charging cycles were recorded to the device memory.The memory content of the icd was inspected.The inspection revealed an elevated charge time, confirming the clinical observation.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: RIVACOR 3 HF-T QP DF4 IS4 PROMRI
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12817236
• Report Number: 1028232-2021-06226
• Device Sequence Number: 5615185
• Product Code: NIK
• UDI-Device Identifier: 04035479156978
• UDI-Public: 04035479156978
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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: 04/30/2021
• Device Model Number: 429571
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown