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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 DDBC3D4
Date of Event 07/25/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient presented at the emergency room due to shocks received from their implantable cardioverter defibrillator (icd).It was noted that there were eleven high rate non sustained episodes, and over one hundred and thirty one non-sustained ventricular tachycardia episodes.As well, the patient's right atrial (ra) lead exhibited far field r-wave (ffrw).Follow up was conducted to no avail.The device is still in use.The lead is still in use.No further 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 Key6920244
Report Number3004209178-2017-20833
Device Sequence Number852195
Product Code LWS
UDI-Device Identifier00643169530294
UDI-Public00643169530294
Combination Product (Y/N)N
Initial Reporter StateTN
Initial Reporter CountryUS
PMA/510(K) Number
P980016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/25/2017
1 Device 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 Date08/14/2018
Device Model NumberDDBC3D4
Device Catalogue NumberDDBC3D4
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/25/2017
Initial Report FDA Received Date10/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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