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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSURE VDD-2 LEAD; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
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MPRI CAPSURE VDD-2 LEAD; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE Back to Search Results
Model Number 5038S-52
Medical Device Problem Code Under-Sensing (1661)
Health Effect - Clinical Codes Arrhythmia (1721); Dyspnea (1816)
Date of Event 02/28/2021
Type of Reportable Event Malfunction
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 experienced dyspnea and palpitations.The right ventricular (rv) lead (implantable pulse generator (ipg) programmed vdd) exhibited atrial undersensing.The lead remains in use.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE VDD-2 LEAD
Common Device Name
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key11561064
Report Number2649622-2021-05612
Device Sequence Number19879536
Product Code DXY
UDI-Device Identifier00613994250155
UDI-Public00613994250155
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2002
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date04/22/2004
Device Model Number5038S-52
Device Catalogue Number5038S-52
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/01/2021
Initial Report FDA Received Date03/24/2021
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
SEDR01 IPG.
Patient Age81 YR
Patient Weight115
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