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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI S 75; ICD LEAD
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BIOTRONIK SE & CO. KG PLEXA PROMRI S 75; ICD LEAD Back to Search Results
Model Number 402267
Medical Device Problem Code Under-Sensing (1661)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/23/2019
Type of Reportable Event Malfunction
Event or Problem Description
This lead was repositioned due to undersensing.No adverse patient events were reported.The lead remains actively implanted.Should additional information be received, this file will be updated.
 
Additional 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
PLEXA PROMRI S 75
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin D-123 59
GM  D-12359
MDR Report Key8285920
Report Number1028232-2019-00245
Device Sequence Number2140916
Product Code NVY
UDI-Device Identifier04035479140038
UDI-Public(01)04035479140038
Combination Product (Y/N)N
Initial Reporter StateOR
Initial Reporter CountryUS
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 01/22/2019
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 Number402267
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/23/2019
Supplement Date Received by Manufacturer02/07/2019
Initial Report FDA Received Date01/29/2019
Supplement Report FDA Received Date02/26/2019
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 Age70 YR
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