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); Pacing Inadequately (1442)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2020

Event Type  malfunction  

Event Description

The lead showed intermittent impedance increases greater than 3000 ohms and ineffective stimulation of the left ventricle.A reprogramming was not possible or showed similar effects.The lead was replaced by another lead of the same design on 20-apr-2020.

Manufacturer Narrative

The returned lead was thoroughly analyzed.During the analysis, the lead was checked visually, electrically, and mechanically.The visual inspection detected ligature marks 48cm distal of the is 1 connector pin.Immediately proximal of the ligature marking, the insulation was found to be damaged and the lead body bent, and conductor fractures of the coils leading to the ring electrodes could also be confirmed.These damages are with high probability the cause of the clinical observation complained about.The position and type of damage is characteristic for massive mechanical stress of the lead due to a lead being situated immediately proximal of the ligature with a narrow bending radius.At 7.5cm, 19cm, 30cm, and 32.5cm, kinks were found in the lead body.The position and type of these damages are characteristic for massive mechanical stress of the lead due to strong pressure onto the generator housing.The manufacturing process of this lead was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.In summary, there were no indications of a material defect or manufacturing error.

• 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
• MDR Report Key: 10014328
• MDR Text Key: 189569202
• Report Number: 1028232-2020-01900
• Device Sequence Number: 1
• Product Code: OJX
• UDI-Device Identifier: 04035479148959
• UDI-Public: 04035479148959
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 408719
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization