MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-75; LV LEAD

Model Number	401182
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that abnormal shock impedance and rv impedance were seen in home monitoring.Arrhythmia was not detected.The patient died.The cause of death is unknown.The patient died between (b)(6) 2021.The general practitioner has no further information regarding the cause of death.
Additional Manufacturer Narrative
The icd and the leads under complaint were not returned for analysis.The analysis is therefore only based on the inspection of the quality documents associated with the manufacture of this particular devices as well as on the available device data.The manufacturing process for these devices was re-investigated, revealing that all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the devices function to be as specified.There was no indication of a material or manufacturing problem.The available device data was inspected.Inspection of the available iegms showed missing intrinsic signals in the left ventricular channel since (b)(6) 2021.On (b)(6), 2021, the device detected a sudden increase of the right ventricular impedance to values greater than 3000 ohms.The corresponding iegm of episode number 738 and following episodes showed missing intrinsic signals in the left as well as the right ventricular channel.In spite of the available information, no conclusion can be drawn regarding the root cause of the sudden right ventricular impedance increase as well as the missing intrinsic signals.An analysis of the devices themselves would be necessary to determine the root cause.

• Brand Name: SENTUS PROMRI OTW QP L-75
• Common Device Name: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13637983
• Report Number: 1028232-2022-01034
• Device Sequence Number: 16687871
• Product Code: OJX
• UDI-Device Identifier: 04035479138431
• UDI-Public: 04035479138431
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• 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
• Report Date (Section B): 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 401182
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2019
• 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: Death
• Patient Sex: Unknown