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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 Codes Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Code Syncope (1610)
Date of Event 12/26/2017
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 right ventricular (rv) lead had dislodged and exhibited high thresholds.It was noted that the patient experienced syncope.The rv lead was repositioned and remains in use.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 Key7255325
Report Number2649622-2018-01104
Device Sequence Number111116
Product Code DXY
UDI-Device Identifier00643169325715
UDI-Public00643169325715
Combination Product (Y/N)N
Initial Reporter StateCT
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,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/08/2018
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 Date05/11/2019
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 12/26/2017
Initial Report FDA Received Date02/08/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age74 YR
Patient Weight150
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