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

Model Number	6947100
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.The exposed svc (superior vena cava) defibrillation coil became extrinsically distorted due to pulling/stretching/overstress.Visual summary analysis of the lead indicated damage at implant.The technician noted the svc coil was stretched from the proximal cross groove towards the distal end of the lead.
Event or Problem Description
It was reported that the lead was attempted to be implanted but not used.The physician noticed that the distal part of the superior vena cava (svc) coil was damaged/stretched.The lead was removed from service and a new lead was implanted.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
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6317908
• Report Number: 2649622-2017-00893
• Device Sequence Number: 16546892
• Product Code: LWS
• UDI-Device Identifier: 00643169535978
• UDI-Public: 00643169535978
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2016

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: 06/13/2018
• Device Model Number: 6947100
• Device Catalogue Number: 6947100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR