MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP S-85; LEAD

Model Number	401180
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pleural Effusion (2010)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient suffered from 39 degree c fever and was diagnosed with pacemaker infection, in the context of stage iv oami with necrotic wounds of the toes of the right foot.Oozing lesion of the pm scar was present.Pleural effusion was also seen.There was loss of contact with ocular revulsion and need for external cardiac massage for a few tens of seconds when going from lying to sitting.The investigator assessed this event as possible related to patients medical history.The patient was hospitalized and external cardiac massage was done.Oxygen and intravenous diuretic were given.Cardiac ultrasound was done.Palliative care was given at home after rejection from surgery.The device remains implanted.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: SENTUS PROMRI OTW QP S-85
• Common Device Name: LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 13978852
• Report Number: 1028232-2022-01668
• Device Sequence Number: 5881461
• Product Code: OJX
• UDI-Device Identifier: 04035479138417
• UDI-Public: 04035479138417
• Combination Product (Y/N): N
• Initial Reporter Country: DE
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 401180
• 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: 04/01/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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