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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Data Problem (3196)

Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neuro stimulator (ins) for failed back surgery syndrome and spinal pain.It was reported that patient thinks there is something wrong with the implantable neuro stimulator (ins).Patient stated he was trying to adjust stimulation but has not been able to.Patient stated he is generally on program a that works very good, but yesterday he got it stuck on program b and was not able to move it back to a.Patient stated when he tries to adjust the stimulation, he also is not able to do that.Patient is not able to turn on the programmer and is not able to adjust the stimulator.Patient stated the programmer is showing him icons he does not know.Patient changed batteries in the programmer last week.Patient is using high energy battery.Patient stated the programmer has not gotten wet and has not been dropped.Patient stated normally when he goes to bed he decreases the stimulation to sleep.Patient states he was pressing the middle gray button on the left hand side which was turning off the ins at night.Patient was using the ins on and off to turn off and on the patient programmer.It was reviewed he will not be able to increase stimulation with the ins powered off.Patient will get batteries.Patient stated he considers this a sudden change in therapy/ symptoms.Patient stated he accidently put the ins on group b and it was so strong it shook him out of the room.Patient was able to increase the stim and resolved the shaking.No further patient symptoms or complications were reported in this event.Additional information was received from the patient it was reported that the patient needed some helping getting device turned back on.Patient said they advised him to get alkaline batteries so he got them and put them in but is still getting funny pictures on his programmer.Patient synced with the patient programmer and it showed charge the ins icon.Patient said stimulation had stopped.Patient said the "goofy thing" was charged to 3/4 yesterday.Patient said normally he does not have to recharge very often he just recharges when it gets below 1/4.Patient communicated with ins and the programmer showed stim off.Patient put the belt on to charge ins and was successful to start a charge session patient said usually he had issues with it to get good connection however today he had 8 black boxes.During the recharging patient coupling went from 8 to 6.Patient was successful to turn stimulation on using the recharger.Patient reported he saw the lightning bolt in the upper left corner however said he did not feel stimulation.During the call patient reported since he got it, he has had 3 or 4 other problems where he cannot seem to control anything.Where it all of a sudden went on d instead of a (where he prefers to keep it and he can adjust both sides, left and right) or will start vibrating.Patient said when it is on d he thinks that it is when adaptive stimulation is enabled.Patient said he has not had any programming changes.It was reviewed once the implant battery was charged enough he should be able to use the programmer to try adjust settings.Patient said earlier this year the health care professional (hcp) did a radio frequency on his upper back got problems up there too and he fell on the ice and broke his arm.Patient will continue to charge and will call back for further support or call his hc p to help him resolve the remaining issues.It was indicated that the upper back problems started prior to implant.Patient stated the hcp wanted to get the lower back taken care of 1st.No further patient symptoms or complications were reported in this event.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type programmer.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient reporting that regarding not being able to adjust stimulation the patient called the manufacturer representative (rep) on the phone and they were able to step them through reprogramming.The patient stated it had been working well since.The patient stated that the problems with their stimulator, not being able to adjust stimulation, settings changing unexpectedly, having problems with stimulation output and back problems had been resolved.The patient stated they think the cause of the programmer not turning on and the unknown icons seen was due to operator error.They stated they believed the this issue was resolved.The patient stated they weighed (b)(6) pound at the time of the event.No further complications were reported/anticipated.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 7650922
• MDR Text Key: 112747591
• Report Number: 3004209178-2018-14670
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 02/18/2016
• 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
• Patient Weight: 129