MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 7 DR-T DF-1; ICD

Model Number	390064
Medical Device Problem Code	Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient received a shock on 10/19, device did not transmit via home monitoring on the morning of 10/20 even though he was by his monitor.Patient came into clinic on 10/20 for device interrogation, and device was unable to be interrogated through several programmers.Due to this device behavior it was decided that the generator needed to be explanted.Device was explanted on (b)(6) 2020.
Additional Manufacturer Narrative
Upon receipt, the icd was visually inspected.The inspection revealed a spot of molten titanium on the icd housing.The icd was subjected to an electrical analysis, confirming that the device could not be interrogated.Therefore, based on the observed symptoms, it is reasonable to assume that a shock delivery into an external short circuit led to a damage of the electrical module.Due to the damage of the electrical module the device could not be interrogated, and the memory content of the device was not restorable.Possible clinical complications that might lead to an external short circuit include, but are not limited to, twiddler syndrome, subclavian crush syndrome or other lead insulation damages.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 which may be related to the observed damage characteristics.Particularly the final acceptance test proved the device functions to be as specified.There was no indication of a material or manufacturing problem.
Additional Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.

• Brand Name: IFORIA 7 DR-T DF-1
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 10720979
• Report Number: 1028232-2020-04551
• Device Sequence Number: 19614234
• Product Code: MRM
• UDI-Device Identifier: 04035479126926
• UDI-Public: 04035479126926
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: 390064
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/25/2020; 09/13/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 10/26/2020; 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR