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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
Device Problems Signal Artifact/Noise (1036); High Capture Threshold (3266)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/23/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical devices: 694765 lead: 1888 tc lead, implanted: (b)(6) 2012.If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) had a low percentage of effective cardiac resynchronization therapy diagnostics (effectivcrt) caused by a possible left ventricular (lv) lead polarization.It was noted that the pacing amplitude spike was high, which indicates a typical polarization artifact with probable capture delay.It was also noted that the right ventricular (rv) lead had high outputs.The device and leads remain in use.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 was performed and no anomalies were found.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) PACEMAKER ELECTRODE
Manufacturer (Section D)
MPRI
road 149 km 56.3
villalba PR 00766
MDR Report Key10206886
MDR Text Key196844581
Report Number2649622-2020-12334
Device Sequence Number1
Product Code OJX
Combination Product (y/n)N
PMA/PMN Number
P060039
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/30/2020
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
Device Operator Lay User/Patient
Device Expiration Date09/16/2012
Device Model Number419578
Device Catalogue Number419578
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/23/2020
Initial Date FDA Received06/29/2020
Supplement Dates Manufacturer Received06/29/2020
Supplement Dates FDA Received06/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DTMA2D1 CRTD; DTMA2D1 CRTD
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