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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 7 HF-T QP DF4 IS4; CRT-D
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BIOTRONIK SE & CO. KG ITREVIA 7 HF-T QP DF4 IS4; CRT-D Back to Search Results
Model Number 401662
Device Problem High Capture Threshold (3266)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 02/03/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device is currently not available for analysis.No conclusion can be drawn at this time.The investigation will be re-opened should additional data become available.
 
Event Description
After the pocket was closed, dft testing was performed and was unsuccessful.The device delivered appropriate shock,however, the patient did not return to normal sinus rhythm (nsr) so external paddles were used.Patient returned to nsr.Ventricular tachy was not primary reason for implant and this device remains actively implanted at this time.
 
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Brand Name
ITREVIA 7 HF-T QP DF4 IS4
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 Key5473761
MDR Text Key39454170
Report Number1028232-2016-00554
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P050023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/15/2016
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
Device Operator Health Professional
Device Model Number401662
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/26/2016
Initial Date FDA Received03/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age85 YR
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