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

Model Number	6996SQ41
Medical Device Problem Code	Over-Sensing (1438)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2017
Type of Reportable Event	Malfunction
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 a right ventricular lead integrity alert triggered for sensing integrity counter and non-sustained high rate.Additional information was requested and it was learned the lead remains in use and there were no patient complications as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received with a continuation of the previously reported event and the lead displayed t wave over-sensing and possible double counting.It was determined to monitor the patient.

• 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: 6555915
• Report Number: 2649622-2017-04914
• Device Sequence Number: 16330196
• Product Code: LWS
• UDI-Device Identifier: 00613994568014
• UDI-Public: 00613994568014
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/16/2018
• Device Model Number: 6996SQ41
• Device Catalogue Number: 6996SQ41
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2017
• Supplement Date Received by Manufacturer: 04/15/2017; 05/26/2018
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 10/04/2017; 06/05/2018
• 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: DDBB1D1 ICD, 4968-25 X 2 LEADS
• Patient Age: 37 MO