MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 5 DR-T PROMRI DF-1; ICD

Model Number 390115

Device Problem Failure to Interrogate (1332)

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

Event Date 05/18/2020

Event Type  malfunction  

Event Description

After an implantation period of approx.34 months, it was reported that the device could not be interrogated and no connection to the renamic could be established.The device was explanted.

Manufacturer Narrative

The returned lead was only available in fragments.Only the proximal part of the lead was returned for analysis.The distal lead fragment, including the rv shock electrode with electrode tip, was missing for the analysis.The returned fragment was inspected visually.Aside from the existing cut though the lead, no damages were detected.The manufacturing process of this device was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.

• Brand Name: IFORIA 5 DR-T PROMRI DF-1
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10171390
• MDR Text Key: 195699471
• Report Number: 1028232-2020-02494
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• 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: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: 390115
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization