MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	694775
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the proximal portion of the lead was returned, analyzed.Analysis indicated that the distal conductor of the lead developed a fracture due to flexing while in vivo.This report is based solely on device analysis.No information to suggest a device related adverse event or product problem was received.If additional relevant information is received, a supplemental report will be submitted.
Event or Problem Description
The lead was returned to the manufacturer, it was analyzed and tested out of specification.The patient is deceased and additional information indicates the death was unrelated to the out of specification finding.

• Brand Name: SPRINT QUATTRO SECURE
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6919646
• Report Number: 2649622-2017-10248
• Device Sequence Number: 807623
• Product Code: LWS
• UDI-Device Identifier: 00613994740939
• UDI-Public: 00613994740939
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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: Lay User/Patient
• Device Expiration Date: 11/21/2014
• Device Model Number: 694775
• Device Catalogue Number: 694775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 10/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR