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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG SELOX JT 53; PACING LEAD
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BIOTRONIK SE & CO. KG SELOX JT 53; PACING LEAD Back to Search Results
Model Number 346368
Medical Device Problem Code High impedance (1291)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/27/2021
Type of Reportable Event Malfunction
Event or Problem Description
Lead capped due to lead impedance greater than 2500 ohms.No adverse patient events reported.Should additional information become available, it will be added to this file.
 
Additional 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
SELOX JT 53
Common Device Name
PACING LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key12728036
Report Number1028232-2021-05937
Device Sequence Number13829722
Product Code NVN
UDI-Device Identifier04035479077860
UDI-Public04035479077860
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P950037
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/27/2021
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
Operator of Device Health Professional
Device Model Number346368
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/01/2021
Supplement Date Received by Manufacturer11/01/2021
Initial Report FDA Received Date11/01/2021
Supplement Report FDA Received Date11/01/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age71 YR
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