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

Model Number 97714

Device Problems Intermittent Continuity (1121); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Nausea (1970); Undesired Nerve Stimulation (1980); Neuropathy (1983); Device Overstimulation of Tissue (1991); Pain (1994); Loss of Range of Motion (2032); Therapeutic Effects, Unexpected (2099)

Event Date 05/22/2015

Event Type  Injury  

Event Description

It was reported that there was an overstimulation sensation.There was stimulation in the wrong location.It was noted that the stimulator had moved.The patient wanted to set up an appointment with the manufacturer representative (rep).It was thought that the problem was out of the realm of the rep that they had been seeing so they thought they were going to see a new person.The implantable neurostimulator (ins) moved out of position about a month ago, (b)(6) 2015.Rhizotomy a week after the ins moved.It was noted that the implanted physician wanted the patient to have an mri.The patient felt a strong stimulation over the body and was reprogrammed and things for were ok for a couple of weeks in (b)(6) 2015.The last two weeks the stimulation was turning on/off, for about 1-10 seconds, and the current had been getting stronger.It was noted that for the last two weeks the ins was not taking a charge at all.It w as noted that a week ago during sex, the patient lost feeling and movement in the legs for about 7 minutes.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 3708140, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708140, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 97740, serial # (b)(4), product type programmer, patient; product id 97754, serial # (b)(4), product type recharger; product id 977a275, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a275, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 3708140, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 3708140, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 977a275, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a275, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Follow up information reported that the patient did not think they did anything to make the device move.It was noted by the patient that they had lost 35 pounds which the surgeon seemed to think had a lot to do with the issue.The patient was reprogrammed once where more adjustments were made and that was "great".The patient would like to have known that the device could be adjusted up and down all at once which would have been helpful to them last fall.The patient stated that they just had a 4th discectomy/hemilaminectomy and that the "show goes on".It was also noted that had debilitating pain with radiculopathy and neuropathy.If additional information is received, a follow-up report will be sent.

Event Description

Additional information received from the patient reported that the battery was placed in a location that is so hard to charge.The patient reported that it is on the right side and they have to turn paddle clockwise until the cord is pointing at 11 o¿clock.It was reported that the bottom of the battery is pushed inside of body and the top part is protruding out.The patient reported that a pencil can practically be rested on it and there is no way the recharger belt can be used.The patient reported that when they first got the implant it was a miraculous change but around 2015 got knocked on butt again unable to work, home bound, and unable to do basic rehab.Patient reported having lot of medication adjustment.

• 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: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 4918066
• MDR Text Key: 6029144
• Report Number: 3004209178-2015-13483
• 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: 03/17/2017

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: 06/14/2015
• 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: 06/22/2015
• Initial Date FDA Received: 07/16/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Date Device Manufactured: 07/24/2014
• 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: 00041 YR