MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 DR-T DF4 PROMRI; ICD

Model Number	429563
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shock impedance values out of range and oversensing with artefacts were observed via home monitoring approx.One week after the implantation.It was decided to exchange the icd and the lead.
Additional Manufacturer Narrative
The icd was received and analyzed.The memory content of the icd was inspected, showing a normal device function while implanted and in service.In a next step, a sensing test was performed, and the device sensed the attached heart signals free of noise.The icd was subjected to an electrical analysis.The ability of the device 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 correct sensing and shock delivery.In particular, the specified energy level was reached.The impedance measurement functions of the icd were tested, showing no anomalies.The icd proved to be fully functional.The analysis of the memory content showed a normal device behavior while the device was implanted and in service.There was no indication of an icd malfunction.Upon receipt, the lead under complaint was subjected to an extensive analysis.The performance of the lead was scrutinized, including a visual, mechanical and electrical inspection.The lead proved to be without fault throughout its inspection.In particular, the values of the parameters measured during the electrical analysis were within the technical specifications.The provided x-ray images were analyzed.The lead showed much slack in the implanted state, an interaction between lead and generator housing cannot be excluded.Prior to the analysis of the devices, the quality documents accompanying the manufacturing process for these devices were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the functions of the devices to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: RIVACOR 5 DR-T DF4 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: 15014909
• Report Number: 1028232-2022-03593
• Device Sequence Number: 12476601
• Product Code: MRM
• UDI-Device Identifier: 04035479156893
• UDI-Public: 04035479156893
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 04/30/2024
• Device Model Number: 429563
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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