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

Model Number	693558
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The full lead was returned and analyzed.Analysis indicated that the helix exceeded specification the number of turns to extend and retract.The distal conductor of the lead was extrinsically over-rotated.The analyst noted that the helix could not be extended due to the distal conductor distorted within the df4 connector pin, and the drive shaft lug stuck behind the retraction stop, visually./over-retracted.
Event or Problem Description
It was reported that during the attempted implant of the right ventricular (rv) lead the helix would not extend.The lead was not used and another lead was successfully implanted.No patient complications have been reported as a result of this event.

• 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: 6923743
• Report Number: 2649622-2017-11618
• Device Sequence Number: 852762
• Product Code: LWS
• UDI-Device Identifier: 00643169535909
• UDI-Public: 00643169535909
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/06/2017

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: Lay User/Patient
• Device Expiration Date: 06/29/2018
• Device Model Number: 693558
• Device Catalogue Number: 693558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2017
• 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: 75 YR