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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC; SPRINT QUATTRO SECURE S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
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MEDTRONIC; SPRINT QUATTRO SECURE S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER Back to Search Results
Model Number 6935M49
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/06/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 a right ventricular (rv) lead was never used due to its shape.The physician noted that there was a curve at the proximal end of the coil and near the connector sleeve without the use of a stylet.The lead was never used.There was no patient involvement.
 
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Brand Name
SPRINT QUATTRO SECURE S
Common Device Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
Manufacturer (Section D)
MEDTRONIC;
8200 coral sea street ne
mounds view MN 55112
MDR Report Key6470703
Report Number2182208-2017-00610
Device Sequence Number10853798
Product Code LWS
UDI-Device Identifier00643169550889
UDI-Public00643169550889
Combination Product (Y/N)N
Initial Reporter StateHI
Initial Reporter CountryUS
PMA/510(K) Number
P920015
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/06/2017
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 Health Professional
Device Model Number6935M49
Device Catalogue Number6935M49
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/06/2017
Initial Report FDA Received Date04/06/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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