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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MPRI ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
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MPRI ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE Back to Search Results
Model Number 419578
Medical Device Problem Code High Capture Threshold (3266)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/21/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical devices: dtmc1d1 crt-d, implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that there was high threshold on the left ventricular (lv) lead.The lead was capped and replaced.No patient complications have been reported as a result of this event.
 
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Brand Name
ATTAIN STARFIX LEAD
Common Device Name
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10387353
Report Number2649622-2020-15189
Device Sequence Number2898556
Product Code OJX
UDI-Device Identifier00885074511986
UDI-Public00885074511986
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P060039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/10/2020
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 Date02/27/2012
Device Model Number419578
Device Catalogue Number419578
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/21/2020
Initial Report FDA Received Date08/10/2020
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; Required Intervention;
Patient Age67 YR
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