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

Model Number	6935M72
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the full lead was returned and analyzed and the helix of the lead had an out of specification analysis result for extension/retraction due to greater than indicated number of turns to extend.The distal lv (low voltage) electrode of the lead was covered in body tissue/fibrotic growth.Visual summary analysis of the lead indicated damage at implant.
Event or Problem Description
It was reported that the during implant of the right ventricular (rv) lead, there was difficulty placing the lead due to difficult patient anatomy.As a result the lead underwent a significant amount of physical manipulation and when the lead was finally positioned in an ideal location, the helix would not extend.The lead was not used and the case was abandoned.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE S
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6467078
• Report Number: 2649622-2017-03114
• Device Sequence Number: 16288716
• Product Code: LWS
• UDI-Device Identifier: 00643169309784
• UDI-Public: 00643169309784
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2017

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: 02/28/2017
• Device Model Number: 6935M72
• Device Catalogue Number: 6935M72
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2017
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: 01/20/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR