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

Model Number	693558
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); Impedance Problem (2950)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	06/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product(s): dtba1d1 crt-d, implanted: (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient¿s right ventricular (rv) lead triggered a lead integrity alert (lia) as well as a lead noise warning for oversensing-noise episodes and lead impedance warnings for rising pacing impedance.Oversensing was also noted upon manipulation of the patient¿s left arm.A fracture of the rv lead was confirmed.The rv lead was capped and replaced.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: 7681881
• Report Number: 2649622-2018-11317
• Device Sequence Number: 19174880
• Product Code: LWS
• UDI-Device Identifier: 00643169535909
• UDI-Public: 00643169535909
• 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: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/13/2017
• Device Model Number: 693558
• Device Catalogue Number: 693558
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 419478 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 88