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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC.; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC, INC.; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 5019
Medical Device Problem Code Impedance Problem (2950)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/24/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported the lead displayed a sudden shock impedance spike.Additionally, the lead was implanted past the use by date.The adapter was removed and replaced.Following, the lead "still shows erroneous impedance." the lead remains in use and no patient complications have been reported as a result of this event.
 
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Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key6783621
Report Number2182208-2017-01372
Device Sequence Number1115484
Product Code LWS
UDI-Device Identifier00613994220288
UDI-Public00613994220288
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/25/2017
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 Date09/03/2017
Device Model Number5019
Device Catalogue Number5019
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/25/2017
Initial Report FDA Received Date08/09/2017
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
6937-58 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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