MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 5 HF-T PROMRI DF4; CRT-D

Model Number 390113

Device Problem Failure to Interrogate (1332)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/12/2015

Event Type  Injury  

Event Description

It was reported that an lvad system by thoratec heartmate iii was implanted in addition to the existing crt-d system on (b)(6) 2015.The heartmate iii has a magnetic hookup of the pump motor.Since the lvad implantation, the crt-d could no longer be interrogated.For this reason, the crt-d system was moved to the right side on (b)(6) 2015.The communication with the crt-d has functioned properly since.No deterioration of the patientstate of health was reported.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based solely on the returned device data.The provided device data were analyzed.The analysis showed that the anti tachycardic therapy functions were activated on (b)(6) 2014 and first deactivated on (b)(6) 2015 at 11:16 a.M.Furthermore, the analysis of the holter entries showed 124 recorded episodes in the period from (b)(6) 2015, which proves that the tachycardia detection was active in this time period.The analysis of the reed monitoring of the icd also showed no anomalies.It is therefore very likely that the therapy functions of the icd were continuously available in that time period.Brief intermittent interruptions of the therapy functions can, however, not be ruled out completely.If additional relevant information should become available, this incident will be updated.

• Brand Name: IFORIA 5 HF-T PROMRI DF4
• Type of Device: CRT-D
• 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: 5330964
• MDR Text Key: 34512410
• Report Number: 1028232-2015-04737
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 390113
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2014
• 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