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

Model Number	6946M55
Medical Device Problem Codes	Capturing Problem (2891); Device Sensing Problem (2917); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Ventricular Tachycardia (2132)
Date of Event	02/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant product(s): a 1642t lead, implanted: (b)(6) 2007.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the day following implant the right ventricular (rv) lead was found to be dislodged.It was noted there was a r-wave change and threshold change.The lead was revised without complication and remains in use.No patient complications have been reported as a result of this event.

• 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: 7418905
• Report Number: 2649622-2018-05312
• Device Sequence Number: 1264005
• Product Code: LWS
• UDI-Device Identifier: 00643169335561
• UDI-Public: 00643169335561
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: 08/19/2018
• Device Model Number: 6946M55
• Device Catalogue Number: 6946M55
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 04/10/2018
• 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; Required Intervention
• Patient Age: 82 YR