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

Model Number	6707-15
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: 6984m adaptor implanted: (b)(6) 2016; 6984m adaptor implanted: (b)(6) 2016; 6984m adaptor implanted: (b)(6) 2016; 6920 adaptor implanted: (b)(6) 2016; 407645 lead implanted: (b)(6) 2010; 693565 lead implanted: (b)(6) 2010; 419688 lead implanted: (b)(6) 2010.Evaluation summary: the crdm adaptor was returned and analyzed.Analysis indicated that the defibrillation coil was flexed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A lead adaptor apparently previously associated with the rv lead was returned to the manufacturer, analyzed, and tested out of specification.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
Additional information was received from the physician's office in response to our follow-up attempts.Markedly elevated impedance, loss of capture, and sensing abnormalities on the rv lead were noted.During explant of the rv lead, the helix did not completely retract.High threshold on the left ventricular (lv) lead was also noted.It was specifically noted this high threshold might have been related to the particular pacing vector chosen (lv tip-rv coil).It was also reported that the lead adaptor had no longer been needed due to relocation of the pocket to the left side.The rv lead was replaced, and the lv lead remains in use.

• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 8067353
• Report Number: 2182208-2018-02073
• Device Sequence Number: 16679601
• Product Code: LWS
• UDI-Device Identifier: 00613994793942
• UDI-Public: 00613994793942
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P920015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 03/29/2018
• Device Model Number: 6707-15
• Device Catalogue Number: 6707-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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