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

Model Number	6996SQ58
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/16/2019
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
The patient reported hearing an alert.Low defibrillation impedance was noted on both the svc coil and rv coil of the patient's subcutaneous leads.The coils were too close together which was triggering the alert.The leads were explanted and replaced with 1 subcutaneous lead.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported/clarified that the patient had 2 revision procedures.During the first procedure, one subcutaneous lead was removed and replaced with an intravenous right ventricular (rv) lead.The following day, the 2nd subcutaneous lead was removed and replaced with a new subcutaneous lead.
Additional Manufacturer Narrative
Product event summary: the full lead was returned, analyzed, 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: SUBQ
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8405807
• Report Number: 2649622-2019-03968
• Device Sequence Number: 1990595
• Product Code: LWS
• UDI-Device Identifier: 00613994568021
• UDI-Public: 00613994568021
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/04/2019

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: 01/15/2020
• Device Model Number: 6996SQ58
• Device Catalogue Number: 6996SQ58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Received by Manufacturer: 02/17/2019
• Supplement Date Received by Manufacturer: 03/22/2019; 04/03/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/28/2019; 04/04/2019
• 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: 4968-60 LEAD, DVAB1D1 ICD, 6996SQ58 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 38 YR