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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO MAXIMO II DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC MED REL MEDTRONIC PUERTO RICO MAXIMO II DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number D284DRG
Medical Device Problem Code Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 03/04/2020
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 the implantable cardioverter defibrillator (icd) was past end of service (eos) and triggered a charge circuit inactive alert.The icd remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
MAXIMO II DR
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key9915853
Report Number3004209178-2020-06579
Device Sequence Number16316207
Product Code LWS
UDI-Device Identifier00613994446602
UDI-Public00613994446602
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/02/2020
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 Lay User/Patient
Device Expiration Date07/28/2010
Device Model NumberD284DRG
Device Catalogue NumberD284DRG
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/09/2020
Initial Report FDA Received Date04/02/2020
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
694758 LEAD, 407645 LEAD
Patient Age52 YR
Patient Weight102
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