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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC, INC. SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6996SQ58
Medical Device Problem Code Material Split, Cut or Torn (4008)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/19/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products.: ddbb1d1 icd, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that during a procedure to repair the aortic valve the subcutaneous lead was cut.The lead was partially removed and replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
SUBCUTANEOUS, UNIPOLAR LEAD
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key10042714
Report Number2182208-2020-00887
Device Sequence Number11378770
Product Code LWS
UDI-Device Identifier00613994568021
UDI-Public00613994568021
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date08/20/2017
Device Model Number6996SQ58
Device Catalogue Number6996SQ58
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/21/2020
Initial Report FDA Received Date05/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
4968-35 LEAD, 4968-35 LEAD, 6937A-52 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age54 YR
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