MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ACTICOR 7 DR-T DF4 PROMRI; ICD

Model Number	429524
Medical Device Problem Codes	High impedance (1291); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pocket Erosion (2013)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this device was explanted due to pocket erosion.
Additional Manufacturer Narrative
A shock impedance abnormality was also observed.The icd and the lead under complaint were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these particular devices as well as on the returned device data.The manufacturing processes for the icd and the lead were re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing processes.The final acceptance tests proved the devices functions to be as specified.The returned device data have been analyzed.The analysis did not show any anomalies.Please note that the icd shows a shock impedance greater than 150 ohms when it is outside the pocket.In conclusion, the devices were not returned for analysis.The review of the quality documents confirmed a regular manufacturing.The analysis of the returned device data revealed no indication of a device malfunction.

• Brand Name: ACTICOR 7 DR-T DF4 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 12336215
• Report Number: 1028232-2021-04608
• Device Sequence Number: 16827579
• Product Code: MRM
• UDI-Device Identifier: 04035479156695
• UDI-Public: 04035479156695
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 429524
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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