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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG COROX OTW-S 85-BP; LV LEAD
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BIOTRONIK SE & CO. KG COROX OTW-S 85-BP; LV LEAD Back to Search Results
Model Number 355149
Device Problem Programming Issue (3014)
Patient Problem Muscle Stimulation (1412)
Event Date 09/17/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
The patient was having issues with diaphragmatic stimulation from this lead when laying flat.The device was reprogrammed and the symptoms subsided.No further complaints when the patient came for the next visit.
 
Manufacturer Narrative
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 Name
COROX OTW-S 85-BP
Type of Device
LV LEAD
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 Key5570001
MDR Text Key42416864
Report Number1028232-2016-01175
Device Sequence Number1
Product Code OJX
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 Nurse
Type of Report Initial,Followup
Report Date 03/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number355149
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2014
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) Other;
Patient Age90 YR
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