MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ELUNA 8 DR-T PROMRI; PACEMAKER

Model Number 394969

Device Problem Impedance Problem (2950)

Patient Problem Discomfort (2330)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Lead check failed for the ra lead and it flipped from bipolar to unipolar mode, twice since implant, and both times there was a slight decrease in impedance.All other values are within normal limits.A change in p-wave amplitude was noted when the lead check is failing, which indicates there could be an issue with the lead.Patient is symptomatic when the ra lead polarity switches to unipolar.The clinician requested disabling lead check.Clinician was advised that lead check is a safety feature for lead failure and disabling this feature removes that safety feature and then walked through to disable lead check.Clinician also resolved conflict of not being allowed to have capture control on and lead check off and also disabled atrial capture control.Clinician stated he would monitor patient and bring in again for further evaluation.

Manufacturer Narrative

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: ELUNA 8 DR-T PROMRI
• 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: 6213858
• MDR Text Key: 63560653
• Report Number: 1028232-2016-05108
• 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: 12/08/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 394969
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2016
• 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: 06/03/2016
• 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): Other
• Patient Age: 61 YR