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

Model Number	6946M55
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Electric Shock (2554); Shock from Patient Lead(s) (3162)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient received more than fifty shocks recently.There was no evidence of significant ventricular arrhythmias.The right ventricular (rv) lead shows poor sensing as was suspected of malfunctioning.The implantable cardioverter defibrillator (icd) was also suspected of malfunctioning.Therefore, since the cause of the shocks could not be identified the physician decided to remove the icd to prevent further shocks.The rv lead remains in use.The patient is enrolled in the product surveillance registry/pan cvg study.No further 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.
Event or Problem Description
It was further clarified that since the implantable cardioverter defibrillator (icd) was removed the right ventricular (rv) lead was capped and remains in the patient.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was later reported that a possible right ventricular (rv) lead fracture was suspected.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was later reported that the shocks were due to lead fracture.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7700800
• Report Number: 2649622-2018-11742
• Device Sequence Number: 19112774
• Product Code: LWS
• UDI-Device Identifier: 00643169335561
• UDI-Public: 00643169335561
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 08/15/2018
• Device Model Number: 6946M55
• Device Catalogue Number: 6946M55
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/31/2018; 06/03/2018; 08/13/2018; 08/08/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/06/2018; 08/14/2018; 08/24/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73