MAUDE Adverse Event Report: MEDTRONIC; ADAPTOR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	672625
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis the full lead was returned and analyzed.Analysis indicated that the distal conductor of the lead became extrinsically fractured due to pulling/stretching/overstress.Visual summary analysis of the lead indicated damage at implant.
Event or Problem Description
It was reported that an adaptor was attempted but not used during implant.The physician noted that the patient had a left side system being moved to their abdomen.The patient's right ventricular (rv) lead coil impedance was high through the adaptor.The lead was tested upon replacement of the adaptor and the impedance levels were normal.The adaptor was explanted 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.

• Brand Name: ADAPTOR
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC;; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6468626
• Report Number: 3004209178-2017-07441
• Device Sequence Number: 591115
• Product Code: LWS
• UDI-Device Identifier: 00721902066801
• UDI-Public: 00721902066801
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2017

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: Health Professional
• Device Expiration Date: 10/28/2017
• Device Model Number: 672625
• Device Catalogue Number: 672625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Initial Date Received by Manufacturer: 01/06/2017
• Supplement Date Received by Manufacturer: 01/06/2017
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR