MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 7 VR-T DF4; ICD

Model Number	390087
Medical Device Problem Codes	Failure to Interrogate (1332); Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient felt a sting on the left side of his chest where the device has been implanted and walked into the er.Er staff put the renamic wand on the patient and got no response.No interrogation.Sales team was contacted and two of the sales team arrived within the hour with two separate renamics, which also could not interrogate the device.A total of three renamics were unable to interrogate the device.Last follow-up showed a battery status of 67 percent.Decision was made that the device was either malfunctioning due to eos or a different defect.
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, a 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.

• Brand Name: IFORIA 7 VR-T DF4
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9322125
• Report Number: 1028232-2019-05045
• Device Sequence Number: 345672
• Product Code: LWS
• UDI-Device Identifier: 04035479127145
• UDI-Public: 04035479127145
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2015
• Device Model Number: 390087
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization