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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-85/49; LV LEAD

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BIOTRONIK SE & CO. KG SENTUS PROMRI OTW QP L-85/49; LV LEAD Back to Search Results
Model Number 408719
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923)
Patient Problems Muscle Stimulation (1412); Shock from Patient Lead(s) (3162)
Event Date 02/26/2018
Event Type  Injury  
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.
 
Event Description
Ous mdr - this patient received inappropriate shocks.The patient also experienced phrenic nerve stimulation and this lv lead was discovered dislodged.The lead was explanted and replaced.
 
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Brand Name
SENTUS PROMRI OTW QP L-85/49
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 Key7348783
MDR Text Key102742773
Report Number1028232-2018-00940
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 03/08/2018
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? Yes
Device Operator Health Professional
Device Model Number408719
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/08/2018
Initial Date FDA Received03/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2017
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;
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