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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 Problem Ambient Noise Problem (2877)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2021
Event Type  malfunction  
Event Description
Noise observed on lv lead with patient arm movement.Sensing vector was programmed lv1-lv2.Reprogrammed to lv3-lv4, and no noise was observed with isometrics.The physician has not made a decision on what action will be taken.Lead remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
 
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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 12359
MDR Report Key11404401
MDR Text Key234431343
Report Number1028232-2021-01014
Device Sequence Number1
Product Code OJX
UDI-Device Identifier04035479148959
UDI-Public04035479148959
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 02/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2019
Device Model Number408719
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/25/2021
Initial Date FDA Received03/03/2021
Supplement Dates Manufacturer Received03/03/2021
Supplement Dates FDA Received03/05/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age61 YR
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