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

Model Number	DVBC3D1
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	10/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.
Event or Problem Description
It was reported the device was implanted and following, migrated from the left chest to the patient¿s armpit.As this was not painful to the patient it remained in use until it was removed and replaced six years later.The replaced device migrated to the armpit and this was very painful for the patient and a revision was performed approximately five weeks later.It was also reported that while the patient does not have an overt infection, it is possible an occult infection is causing the pain.Due to the pain and possibility of infection, the patient was treated with antibiotics and the implantable cardioverter defibrillator (icd) and lead were removed.A sub-muscular re-implant is planned.It was noted the recurrent migration may be due to the patient¿s connective tissue disorder.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 S 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: 6317989
• Report Number: 3004209178-2017-03175
• Device Sequence Number: 10927390
• Product Code: LWS
• UDI-Device Identifier: 00643169530324
• UDI-Public: 00643169530324
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P980016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2016

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: 10/28/2017
• Device Model Number: DVBC3D1
• Device Catalogue Number: DVBC3D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Initial Date Received by Manufacturer: 11/02/2016
• Supplement Date Received by Manufacturer: 11/02/2016
• Initial Report FDA Received Date: 02/09/2017
• Supplement Report FDA Received Date: 09/27/2017
• 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: Hospitalization; Required Intervention
• Patient Age: 36 YR