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

Model Number	401179
Medical Device Problem Codes	Failure to Capture (1081); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
High impedance and a loss of capture was observed on this left ventricular lead after the patient received an appropriate shock.
Additional Manufacturer Narrative
The icd was received and analyzed.Upon receipt, a small fragment of the lv lead was still connected to the is4 header bore of the icd, as mentioned in the complaint description.The memory content of the icd was inspected, showing a normal device function while implanted and in service.The header of the icd was inspected in detail.In agreement with the clinical observation, removal of the lead fragment was difficult.Once the lead fragment could be removed, coagulated blood rests were noted inside the header bore as well as on the lead fragment.Otherwise no anomalies were present.It is reasonable to assume that the coagulated blood let to the reported difficulties during the lead extraction.There was no indication of a material or manufacturing problem.In a next step, a sensing test was performed and the device sensed the attached heart signals free of noise.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a correct sensing and shock delivery.In particular, the specified energy level was reached.In conclusion, the icd was fully functional.There was no indication of a device malfunction.Rests of coagulated blood let to the clinical observation.

• Brand Name: SENTUS PROMRI OTW QP S-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: 10778981
• Report Number: 1028232-2020-04758
• Device Sequence Number: 3884068
• Product Code: OJX
• UDI-Device Identifier: 04035479138400
• UDI-Public: 04035479138400
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted 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): 10/27/2020

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: 04/30/2019
• Device Model Number: 401179
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2017
• 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