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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG STRATOS LV CRT-P

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BIOTRONIK SE & CO. KG STRATOS LV CRT-P Back to Search Results
Model Number 338200
Device Problem Failure to Disconnect (2541)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/18/2016
Event Type  Injury  
Event Description
Rep was advised after the fact that device had been sawed into pieces by surgeon having difficulty removing medtronic lead 4195-88 from lv header. Rep does not have further information regarding events including date of occurrence. Device return has been requested.
 
Manufacturer Narrative
On (b)(6) 2016: an op note provided by the hospital states the associated rv lead was capped during this procedure, due to oversensing. This device had reached eri. Added the explant and event dates. 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.
 
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Brand NameSTRATOS LV
Type of DeviceCRT-P
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 Key5963087
MDR Text Key55129405
Report Number1028232-2016-03314
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number338200
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/20/2016 Patient Sequence Number: 1
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