MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG RIVACOR 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 429532

Device Problems Over-Sensing (1438); Incorrect Interpretation of Signal (1543); No Pacing (3268)

Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

Approx.One month after the implantation, oversensing was reported.The patient was discharged home.Device remains implanted.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

The icd and the lead under complaint were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these particular devices as well as on the returned data.The manufacturing process for these devices was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing.The final acceptance tests proved the devices functions to be as specified.The returned data have been analyzed.Inspection of the available iegms confirmed the clinical observation.Based on the morphology of the signals, the root cause of the noise was not determinable.However, it cannot be excluded that external sources led to this event.Please note that the old lead and icd system implanted on this patient (plexa promri sd 65/16 with sn 81404436 and rivacor 7 hf-t qp df4 is4 promri with sn 84818826) showed a similar behavior, but analysis of the devices revealed no anomalies, which may be an indication of external noise sources as the root cause of the clinical event.Should further relevant information become available, this report will be updated.

Manufacturer Narrative

Additional information on oversensing received.The device incorrectly determined oversensing from ventricular lead was a deadly arrhythmia but did not issue treatment.Oversensing episodes cause a lack of pacing and therefore a period of asystole for the patient.Device and lead remain implanted and will be evaluated further.The icd and the lead under complaint were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these particular devices as well as on the returned data.The manufacturing process for these devices was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing.The final acceptance tests proved the devices functions to be as specified.The returned data have been analyzed.Inspection of the available iegms confirmed the clinical observation.Based on the morphology of the signals, the root cause of the noise was not determinable.However, it cannot be excluded that external sources led to this event.Please note that the old lead and icd system implanted on this patient (plexa promri sd 65/16 with sn (b)(6) and rivacor 7 hf-t qp df4 is4 promri with sn (b)(6) ) showed a similar behavior, but analysis of the devices revealed no anomalies, which may be an indication of external noise sources as the root cause of the clinical event.Should further relevant information become available, this report will be updated.

• Brand Name: RIVACOR 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: 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: 15244952
• MDR Text Key: 298122719
• Report Number: 1028232-2022-04196
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 429532
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1