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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG PROTEGO TD 65/16; ICD LEAD
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BIOTRONIK SE & CO. KG PROTEGO TD 65/16; ICD LEAD Back to Search Results
Model Number 359076
Medical Device Problem Code Positioning Failure (1158)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/03/2018
Type of Reportable Event Malfunction
Event or Problem Description
During the implant of this rv lead it got stuck, and if the physician would have taken it out, it would have pulled out the lv lead which would not provide backup pacing.The physician decided to cap this lead and implant an active rv lead.
 
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
PROTEGO TD 65/16
Common Device Name
ICD LEAD
Manufacturer (Section D)
BIOTRONIK SE & CO. KG
woermannkehre 1
berlin D-123 59
GM  D-12359
MDR Report Key7995511
Report Number1028232-2018-03737
Device Sequence Number427743
Product Code NVY
UDI-Device Identifier04035479100490
UDI-Public(01)04035479100490
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 Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 10/18/2018
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 Number359076
Device Catalogue NumberSEE MODEL NO.
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/18/2018
Supplement Date Received by Manufacturer11/05/2018
Initial Report FDA Received Date10/23/2018
Supplement Report FDA Received Date12/26/2018
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 Age83 YR
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