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

Model Number	6935M72
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	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient received an inappropriate shock due to oversensing of noise, and the right ventricular (rv) lead exhibited high impedances and a possible fracture.The lead was explanted and replaced.During the replacement procedure, the new rv lead was initially placed and exhibited a loss of capture at high levels and high impedances.It was suspected that the lead had fractured as blood was observed in the lumen, which led to the severe placement difficulty.The lead was not used and another lead was implanted.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the partial lead was returned in segments and analyzed.The analysis indicated that the distal conductor of the lead developed a fracture due to flexing while in vivo.The analyst noted that the distal conductor was fractured and a location of the fracture can not be determined because of the small portion of the the lead that was returned.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINT QUATTRO SECURE S MRI SURESCAN
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 9673564
• Report Number: 2649622-2020-02803
• Device Sequence Number: 11484064
• Product Code: LWS
• UDI-Device Identifier: 00643169309784
• UDI-Public: 00643169309784
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 07/15/2017
• Device Model Number: 6935M72
• Device Catalogue Number: 6935M72
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/06/2020
• 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: 73 YR