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 03/25/2019

Event Type  malfunction  

Event Description

Ous mdr - after an implantation period of approx.38 months, it was reported that the icd was not interrogable.

Manufacturer Narrative

After its receipt, the icd was first visually inspected.Spots of locally melted titanium were detected.In a next step, the icd underwent electrical testing.Matching the clinical observation, it was not possible to interrogate the icd.Based on these results, it can be assumed that a shock delivery into an external low-ohmic shock path led to the observed spark-over traces and damage to the electronic module, as result of which the icd could no longer be interrogated.Possible clinical complications that could lead to an external short-circuit are, among other, twiddlers syndrome, subclavian crush syndrome, or other damage to the lead insulation, which lead to a low-ohmic contact of the high-voltage conductors.The manufacturing process of the icd was reviewed.The production documents showed no anomalies.All manufacturing steps had been carried out correctly.A performed standard final electrical test documented proper device behavior.There were no indications of a material defect or a manufacturing error.

• 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: 8516655
• MDR Text Key: 142041898
• Report Number: 1028232-2019-01495
• 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: 03/28/2019

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 Expiration Date: 02/29/2016
• Device Model Number: 390115
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Initial Date Manufacturer Received: 04/12/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1