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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI LEAD END CAP KIT; ADAPTOR, LEAD, PACEMAKER
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MPRI LEAD END CAP KIT; ADAPTOR, LEAD, PACEMAKER Back to Search Results
Model Number 5867-3M
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 6935m55 lead, implanted: (b)(6) 2019; 5086mri52 lead; 5086mri45 lead, implanted: (b)(6) 2013.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) and leads were explanted due to pocket infection.Cultures were taken.Antibiotic treatment was necessary.No further patient complications have been reported as a result of this event.
 
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Brand Name
LEAD END CAP KIT
Common Device Name
ADAPTOR, LEAD, PACEMAKER
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8922712
Report Number2649622-2019-15026
Device Sequence Number253683
Product Code DTD
UDI-Device Identifier00613994500298
UDI-Public00613994500298
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K911048
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/22/2019
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 Date12/15/2019
Device Model Number5867-3M
Device Catalogue Number5867-3M
Device Lot NumberVA12MJ6
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/07/2019
Initial Report FDA Received Date08/22/2019
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
DTMA1D4 CRTD, 511212 X2 GREATBATCH LEADS
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age77 YR
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