MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA NEO 7 VR-T DF-1 PROMRI; ICD

Model Number	429531
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After replacement of the previous icd, it was reported that the shock impedance values were too high.
Additional Manufacturer Narrative
The icd was not returned for analysis.Therefore this investigation is based on the review of the quality documents associated with the manufacture of the icd and the lead as well as the analysis of the returned data and the lead itself.The manufacturing process for the icd and the lead was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test of the icd proved the device functions to be as specified.The returned data were inspected.The inspection revealed that 2 manual shocks were charged on (b)(6) 2019 at 15:06 and 15:08, which were aborted due to a measured shock impedance greater than 150 ohm.As mentioned in the complaint description, the farfield signal was missing in the returned iegm picture.The returned lead was subjected to a thorough analysis.Upon receipt the lead was found cut at approximately 11cm distal to the is-1 connector pin.A proximal and a distal lead fragment were returned.A segment of about 4cm between these two fragments was not returned for analysis.The visual inspection of the lead fragments revealed multiple abrasion marks along the lead body.In the area of the connector pin the insulation was found damaged and the conductor cable to the rv shock coil was found fractured.It is reasonable to assume that this damage led to the clinical observation.Based on the characteristics of the damages, it is reasonable to assume that the lead was subject to severe mechanical stress in the implanted state due to interaction with the generator housing.In conclusion, the clinical observation presumably resulted from the observed lead conductor fracture.There was no indication of a material or manufacturing problem of the lead or the icd.

• Brand Name: ILIVIA NEO 7 VR-T DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 9492249
• Report Number: 1028232-2019-05655
• Device Sequence Number: 2967084
• Product Code: LWS
• UDI-Device Identifier: 04035479156763
• UDI-Public: 04035479156763
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 12/02/2019

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: 09/30/2021
• Device Model Number: 429531
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 12/19/2019
• Supplement Report FDA Received Date: 04/01/2020
• 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