MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG CYLOS DR-T; PACEMAKER

Model Number 349806

Device Problem Pacemaker Found in Back-Up Mode (1440)

Patient Problems Tingling (2171); Patient Problem/Medical Problem (2688)

Event Date 12/15/2016

Event Type  Injury  

Event Description

The patient has surgery on (b)(6) 2016 and the device was interrogated the next day for pacemaker mediated tachycardia.On (b)(6) 2016 the patient felt pocket stimulation and was seen in-office on (b)(6) 2016.The device was in fail safe mode with a message to reset/re-initialize the device.This was successfully done and this pacemaker remains implanted.

Manufacturer Narrative

We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.

• Brand Name: CYLOS DR-T
• Type of Device: PACEMAKER
• 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: 6214828
• MDR Text Key: 63605655
• Report Number: 1028232-2016-05145
• Device Sequence Number: 1
• Product Code: NVZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 349806
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2010
• 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 Age: 60 YR