MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SETROX S 60; PACER LEAD

Model Number 350975

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Nurse received an alert of bipolar lead failure via home monitoring.Polarity switched to unipolar.Patient will be brought into the clinic.Lead remains implanted.

Manufacturer Narrative

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.

Manufacturer Narrative

An updated analysis report was received.The device is currently not available for analysis.Therefore the provided information has been carefully analyzed.The available trend curves showed a stable pacing impedance around 500 ohms between (b)(4) and (b)(4) 2016 with a subsequent decrease down to 300 ohms.Furthermore the provided iegm demonstrated artifacts on the rv channel.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead would be necessary for a root cause investigation.Should additional information or the device itself become available the report will be updated.

• Brand Name: SETROX S 60
• Type of Device: PACER LEAD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 5735371
• MDR Text Key: 47721576
• Report Number: 1028232-2016-02203
• Device Sequence Number: 1
• Product Code: NVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 350975
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2015
• 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 Age: 67 YR