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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI SUREFIX; ELECTRODE, PACEMAKER, PERMANENT
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MPRI SUREFIX; ELECTRODE, PACEMAKER, PERMANENT Back to Search Results
Model Number 5072-45
Medical Device Problem Code Over-Sensing (1438)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/26/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Concomitant medical products: vedr01 ipg, implanted: (b)(6) 2008.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the right atrial (ra) lead exhibited oversensing.The lead remains in use.No patient complications have been reported as a result of this event.
 
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Brand Name
SUREFIX
Common Device Name
ELECTRODE, PACEMAKER, PERMANENT
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key6781816
Report Number2649622-2017-09037
Device Sequence Number1339075
Product Code DTB
UDI-Device Identifier00885074311869
UDI-Public00885074311869
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
P930039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2000
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 05/26/2017
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 Date07/17/2000
Device Model Number5072-45
Device Catalogue Number5072-45
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/26/2017
Initial Report FDA Received Date08/09/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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