MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA AF MRI S; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DDMC3D1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and no anomalies were found.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that shortly after a device changeout procedure, the patients right ventricular (rv) lead had triggered alerts for elevated/high impedance and impedance spikes.An increase in sensing integrity counter (sic) was also noted.It was thought a connection issue between the implantable cardioverter defibrillator (icd) and lead could be the issue.An x-ray was taken and it looked like the lead pin was not fully inserted into the icd header.During the revision procedure the physician could not visualize the lead pin past the grommet.A wrench was used to unscrew the lead pin setscrew and then the physician pushed on the lead and it advanced about 1.5mm.The physician then tightened the setscrew and everything tested normal.The device and lead remain in use.No patient complications have been reported as a result of this event.

• Brand Name: EVERA AF MRI S
• Common Device Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6781851
• Report Number: 3004209178-2017-16888
• Device Sequence Number: 11005226
• Product Code: LWS
• UDI-Device Identifier: 00643169717244
• UDI-Public: 00643169717244
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/28/2018
• Device Model Number: DDMC3D1
• Device Catalogue Number: DDMC3D1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2017
• Initial Report FDA Received Date: 08/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR