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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 07/21/2021
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 the implant procedure, the physician had difficulty when splitting the sheath.The handle separated from the sheath instead of following the tear line. 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 Key12230575
Report Number2182208-2021-02967
Device Sequence Number14235600
Product Code DYB
UDI-Device Identifier00613994391551
UDI-Public00613994391551
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 07/27/2021
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 Date11/10/2022
Device Model Number6207-S5
Device Catalogue Number6207-S5
Device Lot NumberW6120318
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/23/2021
Initial Report FDA Received Date07/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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