MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG DEXTRUS 53 MODEL 4136 US 644136-102; PACING LEAD

Model Number 358754

Device Problems Break (1069); Over-Sensing (1438); Pacing Intermittently (1443)

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

Event Date 01/14/2022

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

This lead was capped due to oversensing with pacing inhibition.There also appeared to be insulation break down from lead on lead interaction.Should additional information become available, this file will be updated.

Manufacturer Narrative

This previously capped lead was explanted due to infection on (b)(6) 2022.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.

Manufacturer Narrative

This previously capped lead was explanted due to infection on (b)(6) 2022.Upon receipt, the lead under complaint was found cut 10 cm distal to the is-1 connector pin.The proximal and the distal fragment were received for analysis.The medial fragment (approximately 30 cm length) was not returned.The analysis showed 10 cm and 8 cm proximal to the lead tip that the insulation 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.Furthermore, a damaged is-1 connector pin was found, which most likely resulted from the extraction procedure.Due to the reported infection the sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally, an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In summary, the infection was not device related.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.In conclusion, the analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: DEXTRUS 53 MODEL 4136 US 644136-102
• 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: 13518677
• MDR Text Key: 285545149
• Report Number: 1028232-2022-00743
• Device Sequence Number: 1
• Product Code: NVN
• UDI-Device Identifier: 04035479143213
• UDI-Public: 04035479143213
• 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,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 358754
• 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: 06/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2013
• 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