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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSURE VDD 2; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
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MPRI CAPSURE VDD 2; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE Back to Search Results
Model Number 5038S-58
Medical Device Problem Code Under-Sensing (1661)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/15/2019
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 intermittent undersensing was noted on the ventricular channel during ventricular high rate episodes.The patient's right ventricular lead was capped and replaced due to upgrade to a cardiac resynchronization therapy defibrillator system.No patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE VDD 2
Common Device Name
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key8410647
Report Number2649622-2019-04139
Device Sequence Number269138
Product Code DXY
UDI-Device Identifier00681490122931
UDI-Public00681490122931
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/12/2019
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 Date03/31/2005
Device Model Number5038S-58
Device Catalogue Number5038S-58
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/15/2019
Initial Report FDA Received Date03/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age84 YR
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