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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 Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated atrial undersensing.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the pacing lead exhibited evidence of atrial undersensing.The 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 Key8730630
Report Number2649622-2019-10834
Device Sequence Number1685181
Product Code DXY
UDI-Device Identifier00643169325708
UDI-Public00643169325708
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 06/25/2019
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 Date11/24/2017
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 10/15/2018
Initial Report FDA Received Date06/25/2019
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
ADVDD01 IPG
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