MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG INTICA 7 HF-T DF-1 IS-1 PROMRI; CRT-D

Model Number	404627
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.The returned device data have been analyzed.There was no indication of a device malfunction.The morphology of the heart signals observed in the available iegms from (b)(6) 2021 shows weaker and weaker signals indicating a dying heart.Based on the data available for analysis the icd functioned and provided therapy as expected.Regarding the time discrepancy mentioned in the complaint description, the available data indicate that the programmer devices used during the follow-ups on (b)(6) 2021 and on (b)(6) 2021 might have had a wrong time.In summary, there was no indication of an icd malfunction.
Event or Problem Description
It was reported that the patient expired on (b)(6) 2021.Shocks were delivered earlier the same evening, but it is unclear if the device clock was accurate at the time shocks were delivered.Based on the data analysis, this event is reportable.

• Brand Name: INTICA 7 HF-T DF-1 IS-1 PROMRI
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• MDR Report Key: 12656281
• Report Number: 1028232-2021-05729
• Device Sequence Number: 4479964
• Product Code: NIK
• UDI-Device Identifier: 04035479142148
• UDI-Public: 04035479142148
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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: 04/30/2020
• Device Model Number: 404627
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 10/19/2021
• 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: Death
• Patient Age: 71 YR