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

Model Number 358754

Device Problem Pacing Intermittently (1443)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Boston scientific's provided the following information: it was reported that this lead was capped due to intermittent pacing inhibition.

Manufacturer Narrative

Upon receipt, the lead under complaint was found cut 12.5 cm distal to the is-1 connector pin.The proximal fragment was received for analysis.The distal fragment including the lead tip was not returned.The returned lead fragment was analyzed.The inspection revealed that the insulation was, apart from the present cut, free of breaches.Further analysis of the returned lead fragment did not reveal any irregularity that might have contributed to the reported clinical observations.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: 12858393
• MDR Text Key: 281141225
• Report Number: 1028232-2021-06359
• 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
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2011
• Device Model Number: 358754
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2009
• 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