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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 High impedance (1291); Ambient Noise Problem (2877)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2022
Event Type  malfunction  
Event Description
Noise seen on this leads intracardiac signal when the patient lifts their arm over their head.Pacing impedance has spiked to greater than 2000 ohms intermittently starting on (b)(6) 2022.Impedance measured in person on (b)(6) 2022 was in normal range.Pacing impedance measured on (b)(6) 2022 was 1.5v, at implant it was 0.5-0.6v.A chest x-ray will be done to verify lead position.Lead remains implanted.Should additional information be received 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
Manufacturer Contact
6024 jean road
lake oswego, OR 97035
8772459800
MDR Report Key14732593
MDR Text Key294268048
Report Number1028232-2022-03141
Device Sequence Number1
Product Code OJX
UDI-Device Identifier04035479148959
UDI-Public04035479148959
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P070008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/16/2022
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 Date02/29/2024
Device Model Number408719
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/16/2022
Initial Date FDA Received06/17/2022
Supplement Dates Manufacturer Received06/21/2022
Supplement Dates FDA Received06/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/21/2022
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 Age78 YR
Patient SexFemale
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