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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 5038-58
Medical Device Problem Codes Over-Sensing (1438); Under-Sensing (1661)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/05/2021
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 right ventricular (rv) lead, programmed to a non-traditional vdd mode, exhibited a possible atrial arrhythmia with under-sensing or a normal rhythm with over-sensing, with some parts of the electrogram (egm) possibly suggesting far field r-wave (ffrw) atrial over-sensing of the qrs complex.The rv lead remains in use.No 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 Key11730424
Report Number2649622-2021-08358
Device Sequence Number3029249
Product Code DXY
UDI-Device Identifier00643169325678
UDI-Public00643169325678
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
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) 04/27/2021
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 Date11/30/2020
Device Model Number5038-58
Device Catalogue Number5038-58
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/06/2021
Initial Report FDA Received Date04/27/2021
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
W1DR01 IPG
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