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

Model Number 97714

Device Problems Charging Problem (2892); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Malaise (2359); Numbness (2415); Sweating (2444)

Event Date 02/01/2016

Event Type  malfunction  

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

The consumer reported that they had profuse sweating, an upset stomach, diarrhea and no symptom control for their lower back and legs.The patient had no symptom relief because they had to keep stimulation low due to other symptoms.The indications for use were failed back surgery syndrome and spinal pain.No device issues reported.The patient reported via a company representative (rep) five months later that his device was not working and he was not feeling well.The patient has been in bed for a while and in a lot of pain.When the device was up to the strength the patient needs, it makes his middle region (stomach and below) all numb.The patient can feel the pressure.The patient can pinch himself and cannot feel anything.The device was on 24 hours a day, it does not seem to do him much good.The patient was wondering if it would take a while.The patient needs information and help with his device.The device was on low and always has it charged up, but has to charge every 2-3 days even though the device was on the lowest setting.The patient wanted to know if this was normal.

Manufacturer Narrative

(b)(4).Additional review indicated the following information was previously reported in mfg report # 3004209178-2016-20376 and does not pertain to this event: ¿the patient reported via a company representative (rep) five months later that his device was not working and he was not feeling well.The patient has been in bed for a while and in a lot of pain.When the device was up to the strength the patient needs, it makes his middle region (stomach and below) all numb.The patient can feel the pressure.The patient can pinch himself and cannot feel anything.The device was on 24 hours a day, it does not seem to do him much good.The patient was wondering if it would take a while.The patient needs information and help with his device.The device was on low and always has it charged up, but has to charge every 2-3 days even though the device was on the lowest setting.The patient wanted to know if this was normal.¿ any additional information pertaining to the above event will be reported as a supplemental report to mfg report # 3004209178-2016-20376.Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.

Manufacturer Narrative

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

Manufacturer Narrative

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

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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6003189
• MDR Text Key: 56936589
• Report Number: 3004209178-2016-20552
• 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,Followup,Followup
• Report Date: 10/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 10/06/2016
• Supplement Dates Manufacturer Received: Not provided; 10/10/2016; 07/23/2018; 08/08/2018
• Supplement Dates FDA Received: 10/10/2016; 09/26/2017; 07/23/2018; 10/04/2018
• Date Device Manufactured: 09/14/2015
• 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 Age: 65 YR