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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 Codes Fracture (1260); High impedance (1291)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/14/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtba1d1 icd, implanted: (b)(6) 2015.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that there was high impedance and possible partial fracture on the left ventricular (lv) lead.The lead was inactivated and remains in the patient.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 Key8892936
Report Number2649622-2019-14292
Device Sequence Number13803129
Product Code OJX
UDI-Device Identifier00885074511986
UDI-Public00885074511986
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
PMA/510(K) Number
P060039
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 08/14/2019
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 Date06/09/2012
Device Model Number419578
Device Catalogue Number419578
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/03/2017
Initial Report FDA Received Date08/14/2019
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
5076-52 LEAD, 694765 LEAD
Outcome Attributed to Adverse Event Required Intervention;
Patient Age66 YR
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