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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA S DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA S DR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number DDBC3D1
Medical Device Problem Code Unable to Obtain Readings (1516)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/31/2019
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 after the implantable cardioverter defibrillator (icd) was implanted and during induction testing post-operative a screen displayed "no inductions performed during current session" when the field representative tried to retrieve data after completing induction testing.It was noted the device detected, and successfully treated during the induction and the device functionality was normal.The device remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
EVERA S DR
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key8368218
Report Number3004209178-2019-03946
Device Sequence Number1346092
Product Code LWS
UDI-Device Identifier00643169720411
UDI-Public00643169720411
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/25/2019
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 Date06/28/2019
Device Model NumberDDBC3D1
Device Catalogue NumberDDBC3D1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/31/2019
Initial Report FDA Received Date02/25/2019
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
5076-52, LEAD / 6945-65, LEAD
Patient Age49 YR
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