MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 5 HF-T QP DF4 IS4 PROMRI; ICD

Model Number	429561
Medical Device Problem Codes	High impedance (1291); Loose or Intermittent Connection (1371); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received and analyzed.The icd was interrogated, revealing the bos battery status.Five charging cycles were recorded in the devices memory.The memory content of the icd was inspected.The available iegms revealed the presence of noise in the right ventricular channel.Otherwise no anomalies were noted.Subsequently the header of the device was inspected in detail.The inspection revealed an intermittently opened connection as root cause for the clinical observation.As a result of this event, processes have been reviewed and relevant staff has been retrained.In accordance to biotroniks post-market surveillance system this occurrence represents a very rare event.The information you provided has been entered into our quality system and will be used to evaluate the device performance throughout our organization to maintain and improve the design and performance of our devices.We appreciate the timely information about your finding and regret the inconvenience that your patient and you experienced.
Event or Problem Description
Impedance higher than 3000 ohm and noise detection were seen.An rv lead issue has been ruled out.A failure of the device header was reported.Device was explanted and replaced.

• Brand Name: RIVACOR 5 HF-T QP DF4 IS4 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: 14271209
• Report Number: 1028232-2022-02248
• Device Sequence Number: 17252947
• Product Code: NIK
• UDI-Device Identifier: 04035479156879
• UDI-Public: 04035479156879
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 03/16/2022

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: 02/28/2021
• Device Model Number: 429561
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2019
• 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