MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG DEXTRUS 60 MODEL 4137 AUNZ 644137-151; PACING LEAD

Model Number 360312

Device Problems Pacing Intermittently (1443); Ambient Noise Problem (2877)

Patient Problems Tachycardia (2095); Dizziness (2194); Presyncope (4410)

Event Date 09/27/2021

Event Type  malfunction  

Manufacturer Narrative

The lead is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Event Description

It was reported that the patient was admitted to the hospital due to dizziness and pre-syncopal episodes occurring over the last 2 weeks and approx.78 months after the dextrus lead implantation.The device check showed tachy events, noise on the rv lead and subsequent inhibition of ventricular pacing.Cardiologist was planning to take patient to theatre to look at implanting new rv lead (and replacing generator).Lead remains implanted.

• Brand Name: DEXTRUS 60 MODEL 4137 AUNZ 644137-151
• Type of Device: PACING LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12673841
• MDR Text Key: 277681926
• Report Number: 1028232-2021-05813
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: DE
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/14/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 360312
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2014
• 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