MAUDE Adverse Event Report: MPRI TRANSVENE CS/SVC; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6937A-35
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that an allied health professional (ahp) called in to inquire about a patient's right ventricular (rv) lead that has recently displayed high/undefined rv defibrillation coil impedance.It was noted that the lead was connected to a competitor device.Testing options were presented to the caller, but it is not known if testing or reprogramming was completed.The lead remains in use.No patient complications have been reported as a result of this event.

• Brand Name: TRANSVENE CS/SVC
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8258597
• Report Number: 2649622-2019-01018
• Device Sequence Number: 1866876
• Product Code: LWS
• UDI-Device Identifier: 00613994492388
• UDI-Public: 00613994492388
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980050
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/17/2019

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: 11/07/2016
• Device Model Number: 6937A-35
• Device Catalogue Number: 6937A-35
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2018
• Initial Report FDA Received Date: 01/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 38