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

Model Number	6947M97
Medical Device Problem Codes	Over-Sensing (1438); Decreased Sensitivity (2534); Capturing Problem (2891); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: ddmb1d4 icd and 383069 lead, implanted: (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) lead triggered a lead integrity alert (lia) for a high number of short v-v intervals.The lead was reprogrammed and 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 rv lead exhibited a decrease in r waves, and increase in thresholds and a dislodgement was confirmed by x-ray.The lead was explanted and replaced.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.No anomalies were found.The distal low voltage electrode of the lead was covered in body tissue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE MRI SURESCAN
• Common Device Name: DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8470787
• Report Number: 2649622-2019-05375
• Device Sequence Number: 16409576
• Product Code: NVY
• UDI-Device Identifier: 00643169550971
• UDI-Public: 00643169550971
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2019

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: 08/15/2020
• Device Model Number: 6947M97
• Device Catalogue Number: 6947M97
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 06/12/2019
• Initial Report FDA Received Date: 04/01/2019
• Supplement Report FDA Received Date: 05/24/2019; 06/20/2019
• 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: LNQ11 ICM
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR