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

Model Number 401182

Device Problems Failure to Deliver Shock/Stimulation (1133); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Event Description

The lead was extracted and another lead was implanted due to lead failure: no stimulation.Should additional information be received, this file will be updated.

Manufacturer Narrative

Upon receipt, the lead under complaint was found cut 7.5 cm distal to the is-4 connector pin.The analysis showed 46 cm proximal to the lead tip that the lead was found squeezed and damaged.In this region the conductor coil was found fractured, which is assumed to be the root cause of the reported clinical observation.Based on the characteristics, as well as the location of the fracture, it is reasonable to assume that the lead was subject to excessive mechanical forces as the result of clavicular-first rib entrapment.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: SENTUS PROMRI OTW QP L-75
• 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: 15298044
• MDR Text Key: 298678305
• Report Number: 1028232-2022-04350
• Device Sequence Number: 1
• Product Code: OJX
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 401182
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2018
• 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): Hospitalization