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

Model Number	6996SQ58
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products - model: 4968-60, lead; implanted: (b)(6) 2016.Non-healthcare professional.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient's right ventricular (rv) defibrillation sub-q coil lead displayed a jump in rv defibrillation coil impedance which had triggered an alert for high/undefined impedance.It was noted that the impedance alerts and high voltage therapies were programmed "off." the lead remains implanted.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.

• 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: 7753665
• Report Number: 2649622-2018-12832
• Device Sequence Number: 1678218
• Product Code: LWS
• UDI-Device Identifier: 00613994568021
• UDI-Public: 00613994568021
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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: 10/15/2016
• Device Model Number: 6996SQ58
• Device Catalogue Number: 6996SQ58
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 10/04/2018
• 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: DTBA1D1, CRT-D / 4968-60, LEAD / 4968-60, LEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR