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

Model Number 386836

Device Problems Break (1069); Failure to Capture (1081); High impedance (1291)

Patient Problems Dyspnea (1816); Palpitations (2467)

Event Date 07/22/2019

Event Type  Injury  

Event Description

Patient presented with shortness of breath and fluttering in her chest.Symptoms were first reported on (b)(6) 2019.On (b)(6) 2019, loss of capture and impedances over 3000 ohms were observed on the lead.Physician suspects lead may be frayed or otherwise damaged.Lead function was turned off and revision procedure has been scheduled.Should additional information become available, this file will be updated.

Manufacturer Narrative

Lead was not working, impedance >3000 ohms.Lead was capped.The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.

• Brand Name: SENTUS OTW QP L-85
• Type of Device: LV LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8947427
• MDR Text Key: 156083329
• Report Number: 1028232-2019-03783
• 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: company representative,study
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 386836
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 55 YR