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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) P

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MPRI ATTAIN STARFIX LEAD; DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P Back to Search Results
Model Number 419588
Device Problems Failure to Capture (1081); Fracture (1260); High impedance (1291); Impedance Problem (2950)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/02/2023
Event Type  Injury  
Event Description
It was reported that left ventricular (lv) lead exhibited non-capture and an increase in impedance to a level that was described as high.The lead was reported to have possibly fractured.The lead was capped.A new lv lead was attempted but not implanted because the guidewire would not advance through the lead lumen.The lead was removed and a different lead was used to complete the replacement.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated the impedance trend of the left ventricular pacing lead was rising.Analysis of the device memory indicated the impedance trend of the left ventricular pacing lead was variable.Analysis of the device memory indicated pacing capture threshold in the left ventricle was high.Concomitant medical products: 694765 lead implanted: (b)(6) 2010; 5076-52 lead, implanted: (b)(6) 2010.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
 
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Brand Name
ATTAIN STARFIX LEAD
Type of Device
DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) P
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer (Section G)
MPRI
road 149 km 56.3
villalba PR 00766
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key16904528
MDR Text Key314930656
Report Number2649622-2023-11717
Device Sequence Number1
Product Code OJX
UDI-Device Identifier00885074511955
UDI-Public00885074511955
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 05/10/2023
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
Device Operator Lay User/Patient
Device Expiration Date12/12/2010
Device Model Number419588
Device Catalogue Number419588
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2023
Initial Date FDA Received05/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
DTMA1D1 CRT-D
Patient Outcome(s) Required Intervention; Hospitalization;
Patient Age66 YR
Patient SexMale
Patient Weight77 KG
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