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

Model Number	401183
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the lv lead dislodged approx.1 month after the implantation.
Additional Manufacturer Narrative
The lead under complaint was not returned for analysis.This report is therefore only based on the analysis of the icd itself as well as the inspection of the quality documents associated with the manufacture of the lead and the icd.Upon receipt, the icd was interrogated, revealing the bos battery status.The header of the icd was visually inspected.The visual inspection revealed that the is4 llll lv set screw was unscrewed and tilted beneath the silicon seal.In this tilted position it is not possible to insert the torque wrench again for final fixation.The inner hexagon of the is4 llll lv set screw were found damaged, which indicates the presence of strong mechanical forces during the icd lead connection.Based on these findings, it is assumed that the set screw was attempted to screw in with a tilted angle and under the presence of strong forces.Beside this, the analysis showed no anomalies.Especially the dimensions of the header bores were confirmed to be within the specifications.Furthermore, the manufacturing process for the devices was re-investigated, revealing that all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the devices functions to be as specified.There was no indication of a material or manufacturing problem.

• Brand Name: SENTUS PROMRI OTW QP L-85
• 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: 12712168
• Report Number: 1028232-2021-05892
• Device Sequence Number: 17203315
• Product Code: OJX
• UDI-Device Identifier: 04035479138448
• UDI-Public: 04035479138448
• Combination Product (Y/N): N
• PMA/510(K) Number: P070008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 401183
• 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: 10/27/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 01/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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