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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. ADAPTOR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC, INC. ADAPTOR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 672637
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/07/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6984m accessory, implanted: (b)(6) 2017; 6984m accessory, implanted: (b)(6) 2017; dtba1d1 device, implanted: (b)(6) 2016; 6984m accessory, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) system was extracted due to infection.No further patient complications have been reported as a result of this event.
 
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Brand Name
ADAPTOR
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key7566703
Report Number2182208-2018-01034
Device Sequence Number2501777
Product Code LWS
UDI-Device Identifier00721902066825
UDI-Public00721902066825
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/04/2018
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? No
Operator of Device Lay User/Patient
Device Expiration Date08/28/2017
Device Model Number672637
Device Catalogue Number672637
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/07/2018
Initial Report FDA Received Date06/04/2018
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
6935-65 LEAD, 4076-45 LEAD, 4194-78 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age70 YR
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