MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG DEXTRUS 60 MODEL 4137 US 644137-102; PACING LEAD

Model Number 358764

Device Problems Over-Sensing (1438); Pacing Intermittently (1443)

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

Event Date 04/12/2022

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

Boston scientific provided the following information: lead explanted due to oversensing and pacing inhibition with no asystole.Should additional information be received, this file will be updated.

Manufacturer Narrative

Dextrus 53, sn: (b)(6).Upon receipt, the lead under complaint was found cut 8 cm distal to the is-1 connector pin.The proximal and medial fragment were received for analysis.The distal fragment including the lead tip was not returned.An extraction aid was found on the medial fragment, it is reasonable to assume that the lead was cut during the surgery.The analysis showed that the medial fragment was found abraded through, which is assumed to be the root cause of the reported oversensing.Based on the characteristics of the damage, it is reasonable to assume that the lead was subject to severe mechanical stress due to constant friction against another implantable device such as a nearby lead.Dextrus 60, sn: (b)(6).Upon receipt, the lead under complaint was found cut 7.5 cm and 11.5 cm distal to the is-1 connector pin.An extraction aid was found on the distal fragment, it is reasonable to assume that the lead was cut during the surgery.The analysis showed that the insulation was found abraded through between 14 cm and 10 cm proximal to the lead tip, which is assumed to be the root cause of the reported oversensing.The insulation damage probably resulted from severe mechanical stress due to constant friction against another implantable device such as a nearby lead.Significant lead motion in the area of the tricuspid valve and interaction with atypical tissues should also be taken into consideration.The quality documents accompanying the manufacturing process for these devices were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the functions of the devices to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: DEXTRUS 60 MODEL 4137 US 644137-102
• Type of Device: PACING 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: 14254938
• MDR Text Key: 290444068
• Report Number: 1028232-2022-02237
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 04035479143220
• UDI-Public: 04035479143220
• Combination Product (y/n): N
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2012
• Device Model Number: 358764
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2010
• 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