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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PERCUTANEOUS LEAD INTRODUCER; INTRODUCER, CATHETER
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MEDTRONIC, INC. PERCUTANEOUS LEAD INTRODUCER; INTRODUCER, CATHETER Back to Search Results
Model Number 6207-S5
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/11/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during an implant procedure, the introducer sheath did not peel away properly.The physician used scalpel to cut it and finish the procedure.No patient complications have been reported as a result of this event.
 
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Brand Name
PERCUTANEOUS LEAD INTRODUCER
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key11823210
Report Number2182208-2021-01943
Device Sequence Number11028084
Product Code DYB
UDI-Device Identifier00643169646278
UDI-Public00643169646278
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K911236
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/13/2021
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 Expiration Date02/09/2023
Device Model Number6207-S5
Device Catalogue Number6207-S5
Device Lot NumberGB6278370
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/11/2021
Initial Report FDA Received Date05/13/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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