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

Model Number	429560
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approx.3 months after the implantation a lead revision was performed and it was decided to exchange the icd during this surgery as it was affected a field safety corrective action, bio-lqc, initiated in march 2021.The lead measurements were normal during the surgery and the lead was connected with the new device and left implanted.The screw in the atrial port of the explanted device was not properly connected.
Additional Manufacturer Narrative
The icd was received for analysis and inspected.Upon receipt the device was interrogated.The interrogation could be properly performed and revealed the bos battery status.All electrical parameters were verified and showed a normal device behavior.Especially, the current consumption and the battery state of discharge were found normal and as expected.There was no indication of a device malfunction.

• Brand Name: INTICA NEO 7 VR-T DF-1 PROMRI
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11729736
• Report Number: 1028232-2021-02082
• Device Sequence Number: 3142371
• Product Code: LWS
• UDI-Device Identifier: 04035479156862
• UDI-Public: 04035479156862
• Combination Product (Y/N): N
• 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): 03/25/2021

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: 05/31/2022
• Device Model Number: 429560
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Initial Date Received by Manufacturer: 04/23/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 07/22/2021
• 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