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

Model Number	371992
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Convulsion/Seizure (4406); Syncope/Fainting (4411)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had a syncopal episode occur while rv threshold testing was performed during a routine follow-up interrogation.Rv threshold test was set to a starting amplitude of 4.0v and a pulse width of 0.4ms.Patients permanently programmed settings for rv were an amplitude of 3.6v and pulse width of 0.4ms.The rv threshold test was set to decrement by one pulse and then return to starting amplitude of 4.0v at pulse width of 0.4ms.During the rv threshold test the renamic programmer froze while at an output less than capture threshold and patient had a sudden loss of consciousness and began to seize.The screen on the renamic programmer was unresponsive to input until the physician removed the programming head and broke telemetry with the device.The programmer was set to print results during testing and was also connected to an external printer.After rebooting the programmer the device was re-interrogated and all permanently programmed settings and parameters were normal.Device remains implanted.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as the returned device data.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The returned data were thoroughly inspected.The inspection of the log data confirmed that a manual ventricular threshold test was performed as part of the follow-up on (b)(6) 2022.During the threshold test the pacing amplitude was initially selected manually and further successively reduced by using the button: reduce test amplitude.At 09:26 am communication between the programmer and the pacemaker was interrupted.Further thorough analysis of the pacemakers device data showed a normal and as expected device behavior.There was no indication of any device malfunction.Should further relevant information become available, this investigation will be updated.

• Brand Name: ENTOVIS DR-T PROMRI
• 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: 15798447
• Report Number: 1028232-2022-05799
• Device Sequence Number: 17305633
• Product Code: NVZ
• UDI-Device Identifier: 04035479115173
• UDI-Public: (01)04035479115173(17)160229
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P950037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 02/29/2016
• Device Model Number: 371992
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 11/15/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2014
• 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
• Patient Age: 63 YR
• Patient Sex: Male