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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Loss of Power (1475); Therapy Delivered to Incorrect Body Area (1508); Component Missing (2306); Battery Problem (2885); Charging Problem (2892); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Additional information received from the patient reported that they needed help turning the ins on.The patient's caregiver was seeing the 'charge ins battery' screen on the programmer and the ins recharger.The patient started a charging session and the battery level was blinking on the first quartile.The patient was advised to charge half was before turning the ins on.The patient had 4 coupling boxes and then 6 after repositioning the antenna.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id: 97754, serial # unknown, product type: recharger; product id: neu_recharger_acc, serial # unknown, product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the scs device had been dead and off for over a month.It was stated that the patient had been in the hospital for a stroke and was in rehab.There was a reported return of pain for a month or so.A manufacturer representative went to the hospital to jumpstart the system and it was charged halfway.The patient programmer showed the low implantable neurostimulator (ins) battery screen.The patient was not able to charge during the call.It was reported that the implantable neurostimulator recharger (insr) screen was blank on (b)(6) 2018.A reset was performed during the call but the issue did not resolve.It sounded like the insr was depleted and the consumer could not find a desktop charger/ac cord.Additional information was received from the manufacturer representative clarifying that the patient's system was discharged but was not overdischarged and no device reset was necessary.It was confirmed during the patient/representative meeting that the patient was getting stimulation coverage but it just was not helping with their source of pain.It was confirmed that the system was working as intended.The patient was borrowing external equipment.It was reported that the ins was not overdischarged and the system was recharged without a jumpstart.The rep said the patient¿s pain pattern was covered with low dose stimulation but their extreme pain was beyond the scope of the scs capabilities.The rep noted that the patient was bed ridden and in poor health.The patient's daughter reported that the insr would not charge the ins and the patient was sent a replacement desktop charger ac cord.It was also reported that the system was not working properly and needs to be checked out.The caller explained that the therapy was not stopping the pain at all; it stopped helping the pain and they had tried several things with the programmer.The caller was directed to the healthcare professional.Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient needed help turning up the device.The patient synced with the device and saw an ins needs to be charged message.The patient stated that they have acute back pain and wants to get the device working again.The patient stated that it has been a mess since easter.The patient was charging with full coupling at the end of the call.The patient was able to charge effectively, but the patient did not confirm stimulation was able to be turned on.The patient said that the charging literature is confusing to them as they are a "visual person." no further complications were reported or anticipated.Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient was experiencing a return of pain as if they didn't have the device implanted.The patient stated that they want to meet with a manufacturer's representative (rep) to check their device or to have it reprogrammed.The patient stated that they tried to increase stimulation, but it didn't help.The patient stated that they think it may be in the wrong location.The patient stated that they did not try any other groups or programs.The patient synced with the device and it showed that stimulation was on.The patient stated that the programmer was showing that they were on group b on p1.The patient switched to program 2 and confirmed that they were at 0.0 volts.The patient was assisted in increasing program 2, but were unable to tell if it is helping since they are laying down.The patient is in therapy as they had a stroke and 2 heart attacks while they were driving leading to a car accident.The patient's therapy was working fine until that happened and they are concerned they device may have moved or something came dislodged.The patient stated that they always had pain, but it got down to a 5 with the device.The patient stated that it is now excruciating.The patient was redirected to their healthcare provider (hcp) to address the change in therapy.No further complications were reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the patient was meeting with their healthcare provider (hcp) on monday.The patient has had shooting pain since the car accident, and memory problems, but the patient's memory has returned.No further complications were reported or 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, 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
• MDR Report Key: 7712100
• MDR Text Key: 115112981
• Report Number: 3004209178-2018-16446
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 07/24/2018; 08/17/2018; 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 07/26/2018; 08/21/2018; 10/04/2018; 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1