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

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 04/01/2018

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 manufacturing representative (rep) and consumer regarding a patient who was implanted with a neurostimulator (ins).Information was reported that the patient's battery turns on by itself at increased amplitudes and shocks the patient.Even after he turns both programs to 0 volts and turns it completely off.The patient claims it turns back on and shocks him again.There are no factors the patient is aware of that may have caused this.The rep made sure over the phone the patient's unit was indeed off and the adaptive stimulation wasn't causing the issues.The patient will be meeting with the rep on tuesday to further troubleshoot.The issue has not been resolved.No further complications were reported.No additional patient symptoms were reported.

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

It was reported that the patient¿s therapy was turning on by itself intermittently.They stated they were sleeping when they felt their stimulation turn on.It was indicated that the stimulation turning on by itself was not related to positional movement.The patient stated that it turned itself on last night around 2am.They stated that this was after they turned the amplitude to 0v and off.It was reported that this had happened on other occasions as well.The patient was advised to keep a diary of when the events occurred.A data file was captured.It was indicated that the patient had four groups a, b, c and d.The patient¿s amplitude was 0v on a, b, and d.It was indicated that this had been happening intermittently for the past several weeks ((b)(6)2018).A data file was received.It was also reported that the patient stated that the report might show something different, but they ¿did everything the same and the stimulator was not performing the way it should¿.They also talked about the possibility have having it taken out, but since they no longer had insurance, they stated the manufacturer should be involved since their device was not performing as it should.The rep stated they got the sense that something wasn¿t right.They stated they tested all of their equipment (patient programmer and charger) and everything was performing as expected.Additional information was received regarding the datafile, where it was reported that an event was found at 3am yesterday ((b)(6)2018) where the stimulation turned on, however it could not be told how it got turned on.It was stated there was no recharging events during this time, so the patient programmer as the most likely tool used.Set one appeared to be the 1.4v programmed amplitude on program 1, so when the stimulation does turn on there is a programmed amplitude.It was indicated that there was further historical usage, but they just emailed a sample to show what they were seeing.Technical services suggested that the patient may be inadvertently pressing the on button (though more common it is the off button) when checking their device.They stated they recommended they look over the data again after they had more diary information.The manufacturer representative (rep) reported that the cause of the patient¿s ins turning on and shocking them was not determined.In conversation with the technical services they stated it was most likely something physiological with the patient.The patient¿s wife stated that they coughed a lot during the nigh, which might cause the sudden jolts during the night.It was reported that actions taken to resolve the issue of the ins turning on and showing the patient was the rep told the patient to record a journal of when the events happened.No other actions were taken.It was indicated that the provided information had been confirmed with the physician.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: 7553704
• MDR Text Key: 109632134
• Report Number: 3004209178-2018-12146
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 06/05/2018

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: 12/14/2018
• 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: 05/25/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 05/31/2018; 05/31/2018
• Supplement Dates FDA Received: 06/05/2018; 06/05/2018
• Date Device Manufactured: 01/16/2018
• 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: 61 YR