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 08/16/2020

Event Type  malfunction  

Event Description

After an implantation period of approx.78 months, it was reported that the device was not "interrogatable" in the hospital.The patient is hospitalized and is monitored.

Manufacturer Narrative

The wrong analysis results were sent with follow up 2.The correct analysis results are now attached.The returned icd was visually inspected after receipt, and signs of abrasion were found at the housing.The initial interrogation confirmed the clinical observation, the device could no longer be interrogated.In the next step, the icd was opened, and the internal structure was examined.Damage to the fuse that separates the battery from the electronic module and to the final shock stages was detected.These damages are with high probability the result of a shock delivery into an external low-ohmic shock path.Due to the damage to the module, the icd could no longer be interrogated.Possible clinical complications that might lead to an external short-circuit are, among others, the twiddler syndrome, the subclavian crush syndrome, or other damage to the lead insulation, which leads to a low-ohmic contact of the high-voltage conductors.The manufacturing process of this device 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 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: 10485090
• MDR Text Key: 205373904
• Report Number: 1028232-2020-03744
• 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,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: 390115
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization