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

Model Number 408719

Device Problems High impedance (1291); Ambient Noise Problem (2877); Device Dislodged or Dislocated (2923)

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

Event Date 09/17/2023

Event Type  malfunction  

Event Description

Home monitoring detected high lv pacing impedance (>3000 ohms).Some noise-like episodes were also seen in the lv endocardial ecg and lead dislodgement is suspected.Lead currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

Lead was received for analysis.Explant date is currently unknown.Upon receipt, the lead was found cut 38 cm distal to the is4 connector pin into two segments.The lead was probably cut during the extraction procedure.The analysis showed that the wire of the conductor coil (which leads from the is4 connector to the lead tip) was found fractured 43 cm proximal to the lead tip, which is assumed to be the root cause of the clinical observations.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.Furthermore, the insulation showed some slight damages, which most likely resulted from the extraction procedure.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-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: 17830805
• MDR Text Key: 324442720
• Report Number: 1028232-2023-04849
• 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: 01/22/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 408719
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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