MAUDE Adverse Event Report: MPRI SPRINT QUATTRO SECURE; DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES

Model Number	6947M72
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
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 right ventricular lead was oversensing t waves.Reprogramming options were discussed and the 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 later reported that the sensitivity was reprogrammed.

• Brand Name: SPRINT QUATTRO SECURE
• Common Device Name: DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8288762
• Report Number: 2649622-2019-01558
• Device Sequence Number: 14062140
• Product Code: NVY
• UDI-Device Identifier: 00643169309739
• UDI-Public: 00643169309739
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

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: 01/20/2018
• Device Model Number: 6947M72
• Device Catalogue Number: 6947M72
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/04/2019
• 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: DVAB1D4 ICD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR