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

Model Number	693575
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
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 was hearing audible tones.An interrogation of the device was performed and it was found that a lead integrity alert was triggered on the right ventricular (rv) lead due to sic (sensing integrity counter) and hrns (high rate non-sustained) episodes.There were also two alerts triggered for rv lead impedance out of range for high/undefined pacing impedance.It was also noted that potential oversensing was observed on stored egms (electrograms).A possible lead fracture was suspected.The rv lead was explanted and not replaced as the patient received a competitor sub q implantable cardioverter defibrillator (icd).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: 7508616
• Report Number: 2649622-2018-08089
• Device Sequence Number: 11311483
• Product Code: LWS
• UDI-Device Identifier: 00613994446114
• UDI-Public: 00613994446114
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2018

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: 10/17/2016
• Device Model Number: 693575
• Device Catalogue Number: 693575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/11/2018
• 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; Required Intervention
• Patient Age: 42 YR