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

Model Number	6996SQ58
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: dtbb1d1 icd, implanted: (b)(6) 2014.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) lead had high/undefined pacing impedance, and high rv/superior vena cava (svc) coil impedance.The lead was capped and replaced.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
As well, the lead was fractured.
Additional Manufacturer Narrative
Product analysis of the device memory indicated the impedance of the right ventricular defibrillation coil was beyond the expected upper range.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: 7581795
• Report Number: 2649622-2018-09567
• Device Sequence Number: 2354991
• Product Code: LWS
• UDI-Device Identifier: 00613994568021
• UDI-Public: 00613994568021
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2018

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: 07/18/2017
• Device Model Number: 6996SQ58
• Device Catalogue Number: 6996SQ58
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/15/2018; 06/08/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 06/08/2018; 06/18/2018
• 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: 5071 LEAD,6996SQ58 LEAD,4968 LEAD,5866 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR