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

Model Number 394973

Device Problem Intermittent Capture (1080)

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

Event Type  malfunction  

Event Description

After an estimated implantation period of approx.28 months, an intermittent loss of capture on the left ventricular channel was observed.

Manufacturer Narrative

The pacemaker under complaint has not been returned.Therefore, the analysis is based on the available device data as well as on the complaint description.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.The described device behavior in regard to left ventricular capture control is as expected and in accordance to specification.In case the algorithm is not able to find a stable threshold the maximum pulse amplitude is set to the programmed start value plus a safety margin of 1.2v which results in 3.6v pulse amplitude in this case which is the specified behavior.There was no indication of a device malfunction.A possible root cause for the described clinical observation could be a lead problem of the implanted left ventricular lead.There are no further information about this lead available as it is a competitor product.

• Brand Name: EPYRA 8 HF-T PROMRI
• Type of Device: PACEMAKER
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9506117
• MDR Text Key: 172300253
• Report Number: 1028232-2019-05702
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• PMA/PMN Number: P070008
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 394973
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization