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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PLEXA PROMRI DF-1 SD 65/18; ICD LEAD
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BIOTRONIK SE & CO. KG PLEXA PROMRI DF-1 SD 65/18; ICD LEAD Back to Search Results
Model Number 414001
Medical Device Problem Code Device Damaged by Another Device (2915)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/04/2020
Type of Reportable Event Malfunction
Event or Problem Description
System was explanted and replaced due to lv lead non functioning due to dislodgement.During extraction, ra and rv lead were damaged.Physician choice to replace icd during lead revision.No adverse patient events were reported.Should additional information become available, this file will be updated.
 
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
PLEXA PROMRI DF-1 SD 65/18
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin 12359
MDR Report Key9769393
Report Number1028232-2020-00973
Device Sequence Number14075558
Product Code NVY
UDI-Device Identifier04035479151003
UDI-Public04035479151003
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 02/11/2020
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 Expiration Date11/30/2019
Device Model Number414001
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/11/2020
Supplement Date Received by Manufacturer03/10/2020
Initial Report FDA Received Date02/28/2020
Supplement Report FDA Received Date03/11/2020
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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