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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD
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THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD Back to Search Results
Model Number 518-067
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 03/15/2018
Type of Reportable Event Serious Injury
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Brand Name
SPECTRANETICS LEAD LOCKING DEVICE
Common Device Name
LLD
Manufacturer (Section D)
THE SPECTRANETICS CORPORATION
9965 federal drive
colorado springs CO 80921
MDR Report Key7408168
Report Number1721279-2018-00039
Device Sequence Number1252102
Product Code DRB
UDI-Device Identifier00813132023065
UDI-Public00813132023065
Initial Reporter CountryUK
PMA/510(K) Number
K142116
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/06/2018
Report Date (Section F) 01/01/2005
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Operator of Device Physician
Device Expiration Date02/22/2020
Device Model Number518-067
Device Catalogue Number518-067
Device Lot NumberFLK18B21A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number0
Concomitant Medical Products
and Therapy/Usage Dates
SPECTRANETICS 13F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 9F TIGHTRAIL DILATOR SHEATH; SPECTRANETICS 9F TIGHTRAIL SUB C DILATOR SHEATH; SPECTRANETICS LEAD LOCKING DEVICE; SPECTRANETICS TIGHTRAIL OUTER SHEATH
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age16 YR
Date Report Sent to FDA01/01/2005
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