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

Model Number 97714

Device Problems High impedance (1291); Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Edema (1820); Inflammation (1932); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.

Event Description

The consumer via the manufacturer representative reported that the implantable neurostimulator (ins) was overdischarged; the patient had not used the ins for over a month but she was not exactly sure how long.The ins was not providing a lot of low back and leg relief, and the pain in her right knee was overriding her chronic pain.The patient did not recall any falls.The patient had stopped using the implantable neurostimulator (ins) several weeks before calling the manufacturer representative because the ins did not seem to provide coverage "like it used to." the decrease in therapy began several months ago, but the patient was unable to pin point the exact time.It was noted that the patient was scheduled for an mri of the right knee on (b)(6) 2016 due to pain and swelling of the knee, and a suspected right meniscus tear.The patient had injured her knee several months ago while mowing the lawn with a push lawn mower; she twisted her knee but did not fall.While troubleshooting over the phone, the patient had used the antenna locate (al) feature of the implantable neurostimulator recharger (insr) to try to wake up the ins.After 5 attempts and no charging response, the manufacturer representative had the patient use physician mode recharge (pmr).At 55 minutes into pmr, the ins battery started to charge normally.The manufacturer representative followed up with the patient later that day, and the patient confirmed the ins battery level was 3/4 full and the patient had used the patient programmer to turn the ins on.Steps for putting the ins in mri mode were reviewed with the patient.It was noted that the patient and manufacturer representative set up an appointment for reprogramming for (b)(6) 2016.On (b)(6) 2016, the manufacturer representative met with the patient to reprogram the power on reset (por) code 0x3908.Impedances checks revealed electrodes 0-7 on the lead to the right of the midline, with the tip in the mid-t8 epidural space had all out of range (oor) impedances greater than 10000 ohms when using any of the 16 electrodes available as reference.Impedance checks of electrodes 8-15 on the lead to the right of the midline, with the tip in the mid-t8 epidural space) revealed impedances within normal limits.The manufacturer representative was able to program lead electrodes 8-15 to provide paresthesia on the patient's low back, hips, buttocks, and thigh.Left side was slightly stronger than the right side, but paresthesia was in the areas of the patient's chronic pain.The manufacturer representative planned to follow up with the patient on (b)(6) 2016, and report the information to the implanting healthcare professional.It was unknown whether the issue was resolved at this time, and the patient's status was alive with no injury.Surgical intervention was not performed or planned.The patient's indications for use included failed back surgery syndrome and spinal pain.

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

Additional information received from the representative reported that the stimulator helped reduce some of the patient's pain after reprogramming was done on (b)(6) 2016.Since only one lead was functional it was noted that the coverage for her left hip and leg were not as good as the therapy for the right since it was the left lead impedances that were all out of range, however, paresthesia was covering the right and left pain areas.It was noted that the patient had some post-op inflammation of her right knee, pain and edema after a surgery for a torn meniscus and bone fragment removal.

Manufacturer Narrative

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

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5865689
• MDR Text Key: 51926254
• Report Number: 3004209178-2016-16576
• 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: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2016
• Date Device Manufactured: 09/08/2014
• 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