MAUDE Adverse Event Report: ST. JUDE MEDICAL, LLC DORSAL SPINE STIMULATOR

Model Number 3228

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abscess (1690); Fever (1858); Unspecified Infection (1930); Chills (2191)

Event Date 08/03/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 i received a dorsal spine stimulator at (b)(6) medical center located in (b)(6) by dr.(b)(6).I was rushed to the emergency department on (b)(6) 2015 after fever/chills and my post-operative wounds blew open with massive amounts of pus, blood and fluid.Admitted for 5 days treated with i.V antibiotics.Infection identified as staph aureus.Discharged on another two weeks of oral antibiotics.Again, on (b)(6) 2015, wounds opened up and put on oral antibiotics.On (b)(6) 2015 saw my surgeon who decided that he would remove the device on (b)(6) 2015.Suffered in the hospital for 10 days receiving i.V.Nafcillin, developed kidney and liver issues that had never occurred before.Picc line inserted for additional 8 weeks of i.V.Antibiotic treatment pos-discharge.Do you have any correlation between infections: dr.(b)(6), st.Jude medical implantable devices?.

• Brand Name: DORSAL SPINE STIMULATOR
• Type of Device: DORSAL SPINE STIMULATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, LLC
• MDR Report Key: 5064153
• MDR Text Key: 25278180
• Report Number: MW5056035
• Device Sequence Number: 1
• Product Code: GZB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/03/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2015
• Device Model Number: 3228
• Device Catalogue Number: 0
• Other Device ID Number: 0
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: LOSARTAN 50 MG DAILY
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 53 YR
• Patient Weight: 78