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

Model Number	693552
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	02/21/2017
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported the patient received an inappropriate shock.It was also reported there was a device sensing and detection problem and the lead noise algorithm and t wave over-sensing algorithm did not prevent the shock.Additionally, the lead displayed high impedance, over-sensing, noise and was fractured.It was stated the noise from the lead ¿caused the shock.¿ re-programming to turn the device ¿off¿ was done.A life vest was placed on the patient and following, the device and lead were removed and replaced.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the full lead was returned in segments, analyzed, and the distal conductor of the lead developed a fracture due to flexing while in vivo.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE S
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6411180
• Report Number: 2649622-2017-02489
• Device Sequence Number: 925015
• Product Code: LWS
• UDI-Device Identifier: 00613994446084
• UDI-Public: 00613994446084
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 10/17/2017

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: 07/02/2014
• Device Model Number: 693552
• Device Catalogue Number: 693552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Initial Date Received by Manufacturer: 03/13/2017
• Supplement Date Received by Manufacturer: Not provided; 05/18/2017
• Initial Report FDA Received Date: 03/16/2017
• Supplement Report FDA Received Date: 05/22/2017; 10/17/2017
• 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: 17 YR
• Patient Weight: 97