MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG EVITY 6 DR-T; PACEMAKER

Model Number	407149
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On the event date, the field rep was contacted to provide support to a doctor and evaluate a pacemaker patient that was at 28bpm.When interrogated, the device showed the message to perform memory dump and to call biotronik.Both leads were evaluated, providing less than 100 ohms impedance (unipolar or bipolar), no capture (a or v), suggesting leads fracture.
Additional Manufacturer Narrative
The pacemaker was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this pacemaker were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.Upon receipt, the pacemaker was subjected to an electrical incoming inspection.During initial interrogation a warning message regarding the battery status was displayed on the programming device.The eri battery status was activated on december 15, 2020.Therefore, the pacemakers memory content was analyzed confirming this observation, the battery voltage decreased faster than expected.The ability of the device to deliver therapies was verified revealing that no anti-bradycardia therapy functionality was present as a result of the battery depletion.During the further course of the analysis, the pacemaker was opened.The visual inspection of the inner assembly showed no anomalies.Subsequent thorough investigations of the electronic module revealed a damaged capacitor leading to an elevated current consumption draining the battery.In summary, a damaged capacitor was identified during analysis leading to the clinical observation.However, the manufacturing records document a normal device production.It is therefore assumed, that the damage occurred after the device shipment, however the date of occurrence was not determinable.

• Brand Name: EVITY 6 DR-T
• Common Device Name: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 11942987
• Report Number: 1028232-2021-03098
• Device Sequence Number: 4101848
• Product Code: NVZ
• UDI-Device Identifier: 04035479147686
• UDI-Public: 04035479147686
• Combination Product (Y/N): N
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: 407149
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown