MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVIA DR; PACEMAKER

Model Number	359524
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Syncope (1610)
Date of Event	10/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
After 2 years, the impedance of the rv lead continued to increase, and the patient experienced syncope a few times.
Additional Manufacturer Narrative
The pacemaker and the lead under complaint were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these particular devices as well as on the returned device data.The manufacturing processes for the lead and the pacemaker were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing processes.The returned device data were inspected thoroughly.The rv impedance trend curve showed a gradual increase from 1400 ohms on october 17th, 2019 to greater than 2000 ohms at the end of the recorded period, as indicated in the complaint.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of lead and pacemaker themselves would be necessary to determine the root cause.Should additional information or the devices themselves become available for analysis, the investigation will be updated.

• Brand Name: EVIA DR
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9416573
• Report Number: 1028232-2019-05357
• Device Sequence Number: 1725179
• Product Code: NVZ
• UDI-Device Identifier: 04035479101299
• UDI-Public: 04035479101299
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 359524
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization