MAUDE Adverse Event Report: MPRI SUBCUTANEOUS, UNIPOLAR LEAD; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6996SQ58
Medical Device Problem Codes	Low impedance (2285); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: qty.2 model: 4968-35, lead; implanted: (b)(6) 2011 model: 4965-35, lead; implanted: (b)(6) 1998 model: dtba1d1, cardiac resynchronization therapy defibrillator (crt-d); implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the right ventricular (rv) defibrillation coil leads and the superior vena cava (svc) defibrillation coil lead all display falling and low impedance.It was noted that the patient was in bad heart failure awaiting transplant and that the impedances were most likely due to fluid between the coils.The defibrillation coil leads remain in use.No patient complications have been reported as a result of this event.

• Brand Name: SUBCUTANEOUS, UNIPOLAR LEAD
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 11226912
• Report Number: 2649622-2021-01582
• Device Sequence Number: 3360677
• Product Code: LWS
• UDI-Device Identifier: 00613994568021
• UDI-Public: 00613994568021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/25/2021

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: 07/18/2017
• Device Model Number: 6996SQ58
• Device Catalogue Number: 6996SQ58
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/25/2021
• 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: 6996SQ58, LEAD / 6996SQ41 , LEAD / 672625, ADAPTOR
• Patient Age: 24 YR