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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 5038-58
Medical Device Problem Codes Intermittent Capture (1080); High impedance (1291); Capturing Problem (2891); Impedance Problem (2950); High Capture Threshold (3266)
Health Effect - Clinical Code Dizziness (2194)
Date of Event 01/03/2019
Type of Reportable Event Serious Injury
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 symptoms of pre-syncope.It was noted that the right ventricular (rv) lead had high thresholds, which had increased rapidly resulting in an intermittent loss of capture.A rapid increase in impedance was also noted.The lead was reprogrammed, and then capped and replaced.No further 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 Key8281243
Report Number2649622-2019-01411
Device Sequence Number16184947
Product Code DXY
UDI-Device Identifier00885074201566
UDI-Public00885074201566
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2010
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 01/28/2019
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date09/08/2010
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 01/03/2019
Initial Report FDA Received Date01/28/2019
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
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age21 YR
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