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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI CAPSURE SENSE LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT
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MPRI CAPSURE SENSE LEAD MRI SURESCAN; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 407452
Medical Device Problem Code Failure to Capture (1081)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/03/2019
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 syncope and that bradycardia was seen on surface electrograms (egm).It was noted that capture could not be confirmed on the right ventricular (rv) lead on stored electrograms (egm).The rv lead was explanted and replaced.No further patient complications have been reported as a result of this event.
 
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Brand Name
CAPSURE SENSE LEAD MRI SURESCAN
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key9515804
Report Number2649622-2019-24397
Device Sequence Number438468
Product Code DTB
UDI-Device Identifier00643169411074
UDI-Public00643169411074
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P830061
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/24/2019
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 Date09/03/2017
Device Model Number407452
Device Catalogue Number407452
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/04/2019
Initial Report FDA Received Date12/24/2019
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
ADDR01 IPG, 5076-45 LEAD
Outcome Attributed to Adverse Event Hospitalization; Life Threatening; Required Intervention;
Patient Age81 YR
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