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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
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MPRI ATTAIN OVER THE WIRE LEAD; PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE Back to Search Results
Model Number 419378
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/05/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: 694758 lead, implanted (b)(6) 2007; 1688tc lead, implanted (b)(6) 2005.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that cardiac resynchronization therapy defibrillator (crt-d) system was removed due to an infection.A new system was implanted five days later.No further patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN OVER THE WIRE LEAD
Common Device Name
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key11387996
Report Number2649622-2021-03804
Device Sequence Number4568564
Product Code LWP
UDI-Device Identifier00885074200729
UDI-Public00885074200729
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
P010015
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/26/2021
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 Date05/08/2009
Device Model Number419378
Device Catalogue Number419378
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/10/2021
Initial Report FDA Received Date02/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age68 YR
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