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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC PUERTO RICO OPERATIONS CO. AMPLIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMB1D1
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 04/17/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 4296-88 lead, implanted: (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient experienced a pocket infection, confirmed with positive cultures of the pocket.Blood cultures were negative.The cardiac resynchronization therapy defibrillator (crt-d) was explanted and the leads were capped.No further patient complications have been reported as a result of this event.
 
Additional Manufacturer Narrative
Product event summary : the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.The device was returned and screening analysis was performed, but no issue was identified requiring full analysis.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
AMPLIA MRI CRT-D SURESCAN
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
MDR Report Key8587832
Report Number3004209178-2019-09061
Device Sequence Number19249296
Product Code NIK
UDI-Device Identifier00643169929616
UDI-Public00643169929616
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
P010031
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 06/24/2019
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 Date04/28/2019
Device Model NumberDTMB1D1
Device Catalogue NumberDTMB1D1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Initial Date Received by Manufacturer 04/18/2019
Supplement Date Received by Manufacturer06/19/2019
Initial Report FDA Received Date05/07/2019
Supplement Report FDA Received Date06/24/2019
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
6947-65 LEAD, 5076-52 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age53 YR
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