MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number MDT-ICD

Device Problems Mechanical Problem (1384); Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Unspecified Infection (1930); Complaint, Ill-Defined (2331)

Event Date 05/27/2016

Event Type  Injury  

Event Description

It was reported by the patient via a medwatch form that the patient's implantable cardioverter defibrillator (icd) was reported to have "shifted and moved." the patient sought a second opinion from a different physician at which time the icd was "moved over and placed in another spot" indicating a pocket/device revision.The patient then reported the device had shifted again and had now eroded through the skin, making the device visible.Patient stated they began to "feel really sick" and the physician prescribed antibiotics for the patient.Patient stated they were "on the verge of going septic so the doctor removed [the device] and said it was corroded." it is unknown if the device was replaced.No further patient complications have been reported as a result of this event.

• Type of Device: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7257419
• MDR Text Key: 99566612
• Report Number: 3004209178-2018-02827
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-ICD
• Device Catalogue Number: MDT-ICD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention