MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Chills (2191); Complaint, Ill-Defined (2331); Collapse (2416)

Event Date 08/26/2016

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative and a patient who was implanted with a neurostimulator for non-malignant pain.It was reported by the patient that since implant they had pain at the implantable neurostimulator (ins) site that did not improve and rather seemed to get worse.The patient stated that they had mentioned this to their health care professional (hcp) at their follow-up appointment.It was reported that they collapsed 2 weeks ago with high fever, they felt terrible, and had chills.The patient was taken to the hospital by ambulance and diagnosed with infection in their back at the pocket.The patient did not know what strain the infection was; however, it was reported to be in their blood.Iv antibiotics were administered for 5 weeks.They explanted the leads and then explanted the implantable neurostimulator (ins) the next day.The scs system was completed removed on (b)(6) 2016.The patient called the manufacturer representative from the hospital and stated that their scs system was infection and had been explanted.The patient was still hospitalized at the time of the report on (b)(6) 2016.The patient reported that they almost died.The patient was in rehab and "suffering terribly."he patient was reported to be alive with injury.The patient stated that they were suffering and wanted compensation.

Event Description

Information indicated that the manufacturer representative and the patient were trying to get in touch with each other.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5986664
• MDR Text Key: 55902422
• Report Number: 3004209178-2016-19999
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2016
• Date Device Manufactured: 10/14/2015
• 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; Life Threatening; Required Intervention
• Patient Age: 57 YR