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

Model Number	694758
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Shock from Patient Lead(s) (3162)
Date of Event	04/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated the criteria for the right ventricular lead integrity alert were met.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.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 had triggered a lead integrity alert (lia) with increased sensing integrity counter (sic) and high rate non-sustained episodes.Additionally an alert for rv lead noise was also indicated.An intervention was completed and the low-voltage pace/sense portion of the rv lead was capped and new low-voltage pace/sense lead was implanted, while the high-voltage portion of the original lead remains in use.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.
Event or Problem Description
It was further reported that the right ventricular (rv) lead had developed a lead fracture which resulted in the patient receiving an inappropriate therapy.No further patient complications have been reported as a result of this event.

• 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: 7560419
• Report Number: 2649622-2018-09163
• Device Sequence Number: 2194132
• Product Code: LWS
• UDI-Device Identifier: 00643169535961
• UDI-Public: 00643169535961
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

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: 05/03/2018
• Device Model Number: 694758
• Device Catalogue Number: 694758
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/01/2018
• 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: DVBB1D1, ICD
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR