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); Device Operates Differently Than Expected (2913)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 02/01/2018

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 consumer regarding a patient who was implanted with a neurostimulator for spinal cord stimulation.It was reported that therapy was turning on by itself.Patient stated that she went to have a ct scan for an unrelated reason and she set her neurostimulator (ins) to 0v on program b laying down.Patient thought she turned it off, but stated it did no stay off.Patient stated she felt it come back on when she got up.Patient stated she wasn't near the patient programmer and it was less than 10 minutes after she thought she turned it off.Patient services (pss) reviewed that if the ins was off, the ins icon wouldn't have a lightning bolt in it.Patient doesn't remember if there was a lightning bolt or not.Pss reviewed that since she felt it after moving positions, what likely happened was that she decreased "lying" to 0v but didn't actually turn off the ins, which was why she initially didn't feel stimulation.Pss stated that after she moved, adaptive stim likely changed to her other position which would have automatically changed the voltage making her feel stim again.It was reported stim on/off was related to positional movement.Patient mentioned that this has happened before.Patient was not able to confirm if ins was actually off because she wasn't aware of the on/off icon on the screen.Patient stated they would monitor but seems to understand the buttons and icons now.Pss was not able to confirm if it was a device malfunction or user error.No further complications were reported/ anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the consumer and healthcare provider.It was reported that the cause of the therapy turning on by itself and the patient feeling it come back on when getting up was due to the fact that the patient had adaptive stimulation enabled.The patient was educated about adaptive stimulation and the issue was resolved.The patient reported that their device was doing what it was supposed to do and they simply didn't understand the adaptive stimulation feature of the product- that stated that the issue was resolved and it was merely a training issue.The issue of the therapy turning on by itself occurred when they had some x-rays scheduled in (b)(6) 2018.They understood that the device should be turned off when having x-rays, mris, or ct scans.No further complications reported.

• 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: 7316389
• MDR Text Key: 101863507
• Report Number: 3004209178-2018-04437
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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: 09/28/2016
• 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: 02/28/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/13/2018
• Supplement Dates FDA Received: 04/06/2018
• Date Device Manufactured: 10/30/2015
• 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: 66 YR
• Patient Weight: 88