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

Model Number 371996

Device Problems High impedance (1291); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018 home monitoring reported that impedances and thresholds were higher than expected.During a followup it was confirmed that the impedance was more than 2500 ohms and the threshold was 7.0v at 1.0ms.During a lead revision for this issue, it was found that the rv lead was in good condition and had good numbers.The physician decided to replace this pacemaker instead.The explant date was not provided.

Manufacturer Narrative

Upon receipt, the pacemaker was interrogated and the memory content was analyzed.The right ventricular lead impedance was documented to be at 800 ohms until (b)(6), 2018.On (b)(6), 2018 a right ventricular bipolar and unipolar lead failure was documented as a result of lead impedance measurements greater than 2500 ohms.Therefore, the header of the device was analyzed.The set screws could be easily screwed in and out.There was no foreign material inside the header bores.All dimensions of the header bores were within the range requested by the standard specifications.The spring elements of the pacemaker did not show any deviations.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.There was no indication of a device malfunction.In addition, the impedance measurement functions of the device were tested using different temperature environments.However, the impedance measurement functions proved to be normal.In conclusion, the device is fully functional.The analysis did not show any deviations from the technical specifications.The analysis did not reveal any sign of a material or manufacturing problem.

• Brand Name: EVIA DR-T PROMRI
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• MDR Report Key: 8203294
• MDR Text Key: 131643492
• Report Number: 1028232-2018-04477
• Device Sequence Number: 1
• Product Code: NVZ
• Combination Product (y/n): N
• PMA/PMN Number: P950037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/16/2018

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
• Device Operator: Health Professional
• Device Model Number: 371996
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization