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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 5038-65
Medical Device Problem Codes Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code Syncope (1610)
Date of Event 09/22/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Product event summary: the proximal segment of the lead was returned, analyzed, and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.
 
Event or Problem Description
It was reported that the patient experienced syncope.The right ventricular (rv) lead had high thresholds and pacing spikes without capture.The rv lead was 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 Key7091792
Report Number2649622-2017-13847
Device Sequence Number1874642
Product Code DXY
UDI-Device Identifier00885074201573
UDI-Public00885074201573
Combination Product (Y/N)N
Initial Reporter StateNV
Initial Reporter CountryUS
PMA/510(K) Number
P890003
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2007
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/06/2017
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 Date09/17/2007
Device Model Number5038-65
Device Catalogue Number5038-65
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/22/2017
Initial Report FDA Received Date12/07/2017
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
(B)(4) IPG
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age68 YR
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