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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. COMPIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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MEDTRONIC PUERTO RICO OPERATIONS CO. COMPIA MRI CRT-D SURESCAN; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Model Number DTMC1D1
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hematoma (1884)
Date of Event 05/20/2019
Type of Reportable Event Serious Injury
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 patient required a hematoma evacuation approximately two weeks post-cardiac resynchronization therapy defibrillator (crt-d) implant.The device remains in use.No further patient complications have been reported as a result of this event.
 
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Brand Name
COMPIA 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 Key8674902
Report Number3004209178-2019-11038
Device Sequence Number14043254
Product Code NIK
UDI-Device Identifier00643169837706
UDI-Public00643169837706
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P010031
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) 06/06/2019
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 Date06/28/2019
Device Model NumberDTMC1D1
Device Catalogue NumberDTMC1D1
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/20/2019
Initial Report FDA Received Date06/06/2019
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
419378 LEAD, 6944-65 LEAD, 5076-52 LEAD
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age83 YR
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