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

Model Number	6944-65
Medical Device Problem Codes	Over-Sensing (1438); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Chest Pain (1776); Shock from Patient Lead(s) (3162)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lead integrity alert (lia) triggered and the patient was admitted to the emergency room with chest pain due to inappropriate shocks by the right ventricular (rv) lead.The right ventricular (rv) lead had dislodged and was found to have oversensing with high rate non-sustained (hr-ns) and sensing integrity counter (sic) episodes.The lead was attempted to be repositioned but would not stay in place.The lead was removed and a new lead was implanted.It was further reported that the right atrial (ra) lead had dislodged.The lead was repositioned and remains in use.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.Analysis was performed and no anomalies were found.Visual analysis of the lead indicated apparent explant damage.If information is provided in the future, a supplemental report will be issued.

• 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: 6627713
• Report Number: 2649622-2017-06960
• Device Sequence Number: 395571
• Product Code: LWS
• UDI-Device Identifier: 00643169451469
• UDI-Public: 00643169451469
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2017

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: 07/20/2018
• Device Model Number: 6944-65
• Device Catalogue Number: 6944-65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 04/28/2017; 07/20/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 10/04/2017; 10/06/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 64 YR