MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37713

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Staphylococcus Aureus (2058); Sepsis (2067); Complaint, Ill-Defined (2331); Fluid Discharge (2686)

Event Date 01/01/2016

Event Type  Injury  

Manufacturer Narrative

Event date is an approximate.The patient noticed the surgery was contaminated and destroyed the unit in 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome.It was reported that the patient had the stimulator in until (b)(6) 2016.The patient explained that she had septic and stated that it destroyed the unit.The patient stated she also had a staph infection.The patient stated she had another surgery that was contaminated.The surgery had staph in it and it went unnoticed for 3 years.The patient said she almost got septic last year and almost died and they had to take everything out on (b)(6) 2016.The patient no longer has the stimulator implanted and said it was completely engrossed in staph.The patient said she did not know that the surgery was contaminated and had staph until they opened her up on (b)(6) 2016.The patient further stated that there was a bulge with drainage coming out.The patient said at her last surgery they had to correct everything, and she no longer can have an internal tens unit.The patient stated she still has severe back pain and the back pain was a preexisting issue.No further complications were reported.

• Brand Name: RESTORE ADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7258818
• MDR Text Key: 99592068
• Report Number: 3004209178-2018-02948
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• 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: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2008
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2018
• Date Device Manufactured: 05/10/2007
• 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): Required Intervention
• Patient Age: 52 YR