MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 3 DR-T DF-1; ICD

Model Number 383570

Device Problem Programming Issue (3014)

Patient Problem Syncope (1610)

Event Date 05/29/2018

Event Type  Injury  

Event Description

Ous mdr - patient presented to the emergency department unconscious and therapy on this icd was discovered disabled.

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore based on the returned device memory data and the existing production documents.The manufacturing process of this device was reviewed.The production documents did not show any anomalies.All manufacturing steps had been carried out correctly.A performed standard final electrical test documented proper device behavior.The device memory data were analyzed.The analysis showed that the detection was turned off during the follow-up on (b)(6) 2018 at 12:20 p.M.And that it was only turned on again on (b)(6) 2018 at 2:45 p.M.Thus, no therapy by the icd could take place during this time period.No indication of a device malfunction was found.In summary, there is no indication of a device malfunction.

• Brand Name: IFORIA 3 DR-T DF-1
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin D-123 59; GM D-12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 7641695
• MDR Text Key: 112458210
• Report Number: 1028232-2018-02122
• Device Sequence Number: 1
• Product Code: MRM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 383570
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization