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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ETRINSA 8 HF-T; CRT-P
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BIOTRONIK SE & CO. KG ETRINSA 8 HF-T; CRT-P Back to Search Results
Model Number 394919
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2018
Event Type  malfunction  
Event Description
Physician initially opened the pocket to reposition the device after migration, but decided to explant and replace it to minimize the need for future surgeries.No adverse patient events were reported.Should additional information be received, this file will be updated.
 
Manufacturer Narrative
The device was received and visually inspected.The device was normal and expected,there was no indication of a deviation from the mechanical specification.A review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the device was mechanically as expected.The root cause for the observed device migration could not be determined.
 
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Brand Name
ETRINSA 8 HF-T
Type of Device
CRT-P
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin D-123 59
GM  D-12359
MDR Report Key8283655
MDR Text Key134305428
Report Number1028232-2019-00243
Device Sequence Number1
Product Code NKE
UDI-Device Identifier40354791317770
UDI-Public(01)40354791317770
Combination Product (y/n)N
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number394919
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2019
Date Manufacturer Received02/18/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age31 YR
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