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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The consumer via the manufacturer's representative reported the patient experienced shocking sensations when the implantable neurostimulator (ins) battery voltage was less than 25%.The shocking was in her ribcage and would last a few minutes until she charged past 25%.Once the patient would charge past 25%, the shocking in the ribs resolved.Impedances were good as they were under 1000 ohms.The leads were implanted staggered and the tip stopped at t7.There were no traumas or falls that could have been related to this issue.The patient did not experience symptoms when the ins was off.Shocking only occurred when the ins battery voltage was less than 25%.This issue occurred suddenly on (b)(6).Relevant medical history included chronic low back pain, radiculopathy, and spinal pain.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Event Description

Additional information received from the manufacturer's representative (rep) reported the rep saw the patient and had the clinician programmer software card.

Manufacturer Narrative

Evaluation conclusion code was corrected upon further review.

Event Description

Additional information received from the manufacturer's representative (rep) reported the clinician programmer card was sent back to technical services for analysis.Nothing remarkable was seen on the report that would explain the patient's complaint of shocking when stimulation was below 25%, unless they were just not getting as much pain relief when the implantable neurostimulator (ins) was close to be discharged.This was speculation.It was noticed that the lying back position, they had a larger range of amplitudes that they had tried of 3.4 minimum and 5.3 maximum.It was unknown if this was related.Further, the rep reported the patient claimed to continue to have the same issues.The device was turning off on its own for about 35-50 minutes.The patient could not confirm that information and the rep believed it might just be the perception of the patient regarding the therapy as there were other issues going on as well.The patient was feeling like the stimulation was turning off 6-12 times per day and had to move into a certain position to get the stimulation back.This occurred when the patient was at a physical therapy session walking on a treadmill.The patient felt that the pain treated by stimulation came back within a few seconds when the stimulation turned off.The rep would be following up with the patient son and would try to recreate the positional issue to get impedances at that time.It was noted the rep would be in the operating room on (b)(6) 2016, and requested a return call.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional.The patient's baseline weight was reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient via a healthcare professional of a clinical study.It was reported that the battery held the charge for only two days and shocked the ribs when it was almost out.The patient also stated that there was possibly was fluid between the connection (e.G.Shocking of the ribs).The healthcare professional of the clinical study indicated there was no documentation regarding painful stimulation.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional of the clinical study.A clinical diagnosis of painful rib stimulation with no device diagnosis was reported.The device was interrogated on (b)(6) 2016 and revealed a normal response and normal impedance.On (b)(6) 2016, the patient met with the manufacturer representative and complained of the feeling that her stimulation was "turning off and on".Upon attempting to reset the sensor, the representative noticed that when she was about 45 degrees between left and flat back in which the battery indicated lying back.The patient reported a recent weight loss which the representative suspected allowed the generator to shift in the pocket a bit to offset the correct orientation.The battery shifted in the pocket.He noted that he doesn't believe the battery was turning off but that it was likely the body's perception to feeling it less and more depending how she was positioned.A device diagnosis of ins migration and a clinical diagnosis of loss of stimulation was reported.The migration was related to the device or therapy and possibly related to the implant procedure.No action was taken and the ins migration was unresolved with no further action planned.The device was interrogated on (b)(6) 2017 and the device returned a normal response.It was also noted that the battery was only two years old and would not be replaced.The representative noted the charging interval was in line with the programming.The painful rib stimulation event was possibly related to the device or therapy and was not related to the implant procedure.The event was ongoing.

Manufacturer Narrative

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

Event Description

Additional information was received from the health care provider (hcp) of a clinical study reporting that the outcome was unresolved at the time of the study exit/death/study closure.Follow up is being performed to get clarification of what this means.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer representative.It was reported that the patient was exited from the study on (b)(6) 2018 because the site closed.No further complications were reported/anticipated.

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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5410773
• MDR Text Key: 37848792
• Report Number: 3004209178-2016-01537
• 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: 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

• Date FDA Received: 02/04/2016
• 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
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/23/2015
• 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: 00048 YR
• Patient Weight: 91