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

Model Number	694775
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	10/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the lead has been returned; however physical analysis is pending.The lead performance data collected from the device was received and analyzed.Analysis of the device memory indicated cross chamber oversensing associated with the right ventricular lead.It also indicated oversensing due to non-physiologic signals/sic (sensing integrity counter), and the unexpected delivery of a ventricular tachyarrhythmia therapy.Concomitant medical products: ddbc3d1 icd, implanted (b)(6) 2016; 5076-65 lead, implanted: (b)(6) 2016; medtronic dbs lead x2 implanted: unknown; medtronic neuro extension x2 implanted: unknown.
Event or Problem Description
It was reported that the right ventricular (rv) lead had dislodged and pulled back into the atrium.The lead then sensed both atrial and ventricular signal resulting in inappropriate shocks.The lead was removed and a new lead was implanted.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned and analyzed.Analysis was performed and no anomalies were found.Visual summary analysis of the lead indicated apparent explant damage.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6160484
• Report Number: 2649622-2016-14149
• Device Sequence Number: 11006936
• Product Code: LWS
• UDI-Device Identifier: 00613994740939
• UDI-Public: 00613994740939
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2016

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: 09/23/2016
• Device Model Number: 694775
• Device Catalogue Number: 694775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Initial Date Received by Manufacturer: 10/05/2016
• Supplement Date Received by Manufacturer: Not provided; 12/13/2016
• Initial Report FDA Received Date: 12/09/2016
• Supplement Report FDA Received Date: 02/09/2017; 09/26/2017
• 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: (B)(4) IPG
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 67 YR