MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. EVERA XT VR; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER

Model Number	DVBB1D1
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	11/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient felt a shock ¿ self-described as a "tingle all over [the patient's] body" ¿ after which an audible alert tone was heard.From an interrogation three days later, intermittent t-wave oversensing was observed on the right ventricular(rv) lead, and a change to rv sensitivity was recommended.Approximately three weeks later, the patient reported experiencing multiple shocks per day with ¿tingling.¿ the patient also reported having had an infection after implant.The device and rv lead remain in use.No further 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: EVERA XT VR
• 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: 6317017
• Report Number: 3004209178-2017-03069
• Device Sequence Number: 19223501
• Product Code: LWS
• UDI-Device Identifier: 00643169530300
• UDI-Public: 00643169530300
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2016

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: 01/14/2018
• Device Model Number: DVBB1D1
• Device Catalogue Number: DVBB1D1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/23/2016
• Supplement Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 02/09/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 694758 LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 60 YR