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

Model Number 97712

Device Problem Break (1069)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Swelling (2091); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Chills (2191); Discomfort (2330); Complaint, Ill-Defined (2331); Malaise (2359); Electric Shock (2554)

Event Date 05/30/2015

Event Type  Injury  

Event Description

It was reported that the patient has two brain tumor surgeries and her brain tumors are the reason she had a mri compatible device implanted.The patient stated that she had an aneurysm to her heart and that she needs to have a cat scan with doppler.The patient reported that she will not go to the emergency room because they don¿t know anything about spinal cord stimulation.The patient stated that she has massive brain injuries and is lucky that she was able to communicate.It was stated that the patient had been in bed in terrible pain on the side where the implant was put in and when the implant was on the patient had never felt such pain surging through the left side of the body like crazy.The pain was where the implantable neurostimulator (ins) was and the patient turned the ins off and she had her chronic pain, but ¿whatever was going on with the thing stopped.¿ the patient stated that it felt like fire going through her body and that the ins was working really well prior to this and she never had pain at the ins site before.It was reported that it felt like a lead broke free because when she had the ins turned on it felt like electricity spewing through her body and the patient hadn¿t done anything to cause it.The patient also stated that she may have an infection and that her pain threshold level was off the charts.The patient was dealing with a ¿broken something inside my body¿ and was miserable and was getting sorer and her back was getting more inflamed.The patient expressed her frustration regarding the event and noted it was ¿swelling up.¿ the patient had programming done and the ins was working well after that.If additional information is received a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, product type lead; product id 97740, serial # (b)(4), product type programmer, patient; product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2015, product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the stimulation was no longer covering her pain which was occurring daily and her normal pain was increasing.This was considered a gradual change in therapy/symptoms.The stimulation was not covering the pain and the vibration was too strong making the patient fell nauseous.The vibration had to be too strong in order to cover her pain.The patient had 24 screws in her body which maybe the issue with her feeling sickly when the stimulation was turned up too high.The patient was scheduled for a reprogramming.The patient stated that the only time she had relief was when the ins was reprogrammed.The trial went great but was having problems since implant according to the patient.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the patient was still having concerns regarding his device or therapy but she was working with her doctor or manufacturing representative (rep).An appointment was schedule for (b)(6) 2015.The patient had gone into a cold sweat and severe pain until they turned off the unit.Only one side was on now and it was nowhere near the original relief.It was like she was "1/2 a car repaired" and this was not resolved.She had an x-ray, blood work, and had to make an appointment with her surgeon.It was also noted that the patient had felt a surge of pain that traveled to the bottom of her heart and it felt like her heart was vibrating.The surge of pain was through her body and she could feel the stimulation vibrating through her.The cold sweat started first then the surge hit.The painful surge stopped after turning off stimulation.There were no falls or trauma but the lead was not functioning.The patient met with a manufacturing representative (rep) and tried to reprogram the implantable neurostimulator (ins).The rep turned on the 2nd lead and the patient broke out in a cold sweat and just before the surge of pain started, the rep turned off the 2nd lead.The patient saw the surgeon yesterday and the doctor wanted to schedule another reprogramming appointment with the rep, but the patient did not want to go through the pain again.The doctor did an x-ray on (b)(6) 2015 and told the patient yesterday and the x-ray showed the leads looked fine and that they looked like they were in the correct place.The patient had an appointment with a rep in 3 days.The patient wanted to know what had to do if she decided she no longer wanted the implant in her body.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4853507
• MDR Text Key: 21832639
• Report Number: 3004209178-2015-11835
• Device Sequence Number: 1
• Product Code: GZB
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2015
• Initial Date FDA Received: 06/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2015
• Date Device Manufactured: 05/04/2015
• 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): Required Intervention
• Patient Age: 00053 YR