MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-85/49; LV LEAD

Model Number 408719

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Cardiac Arrest (1762); Unspecified Infection (1930)

Event Date 02/10/2021

Event Type  Death  

Manufacturer Narrative

The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Event Description

The patient suffered from s.Aureus sepsis, secondary to phlebitis in the right arm, congestive heart failure and chronic kidney disease.The patient also had acute pulmonary edema, recent onset af, acute renal failure, metabolic acidosis and chronic anemia.Due to s.Aureus sepsis, possible endocarditis of the atrial lead (ctr-d) was seen.Later, the patient had permanent af, dyspnea at rest, decreasing diuresis, edema in lower extremities, weight gain.It was worsening with a tendency to sleep and fever.Later, the patient died in the hospital due to sepsis by s.Aureus.The event has been assessed as possibly related to the patients medical history by the investigator.The patient was hospitalized several times, and treated with apixaban, cloxacillin pump (at home), levofloxacin and rifampicin.There was normal functioning of the crt-d.

Manufacturer Narrative

(b)(6) 2022 received notification that the patient died at the hospital due to sepsis.The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: SENTUS PROMRI OTW QP L-85/49
• Type of Device: 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: 12623568
• MDR Text Key: 276131634
• Report Number: 1028232-2021-05640
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479148959
• UDI-Public: 04035479148959
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• 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
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 408719
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2019
• 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
• Patient Outcome(s): Death