MAUDE Adverse Event Report: MEDTRONIC, INC. UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	6721S-50
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 6721m-50 lead, implanted: (b)(6) 2009.4968-60 lead, implanted: (b)(6) 2009.511212 oscor lead, implanted: (b)(6) 2009.511211 oscor lead, implanted: (b)(6) 2009.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that alerts were triggered due to low impedance on the svc coil and rv coil of the right ventricular (rv) defibrillation leads.The leads remain in use.No patient complications have been reported as a result of this event.

• Brand Name: UNIPOLAR, EPICARDIAL, OVAL PATCH LEAD, DF1
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; mounds view
• MDR Report Key: 10349766
• Report Number: 2182208-2020-01406
• Device Sequence Number: 16726743
• Product Code: LWS
• UDI-Device Identifier: 00681490148818
• UDI-Public: 00681490148818
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P900061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: 10/28/2009
• Device Model Number: 6721S-50
• Device Catalogue Number: 6721S-50
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 98