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

Model Number 97715

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 01/10/2018

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 patient with an implantable neurostimulator (ins) for spinal pain.The patient stated that their i mplant was working okay but then they met with their manufacture representative (rep) at their primary care physician (pcp) appointment and the rep activated the adaptive stimulation.Since that appointment on (b)(6) 2018, the patient is having issues of losing stimulation.They will lose stimulation after 15 minutes and have a return of pain.The stimulation will turn off and on by itself in 30 second intervals.They use their controller to turn the stimulation on, which resolves it until 15 minutes later.It occurs with or without adaptive stimulation enabled and in any position.When they sync it does not display that the stimulation is off, but when they press the stimulation power button the stimulation turns on and they feel it again.The patient is currently on group a and has program 1 and 5.0.They do not have additional groups programmed and they do not have access to the cycling feature on their program.The patient spoke with their rep on either (b)(6) 2018 who redirected them to call patient services so the patient would like an email to be sent to the local rep.The patient has an appointment with their pcp on (b)(6) 2018.An email was sent to the local rep.Additional information was received from the rep on (b)(6) 2018.The rep stated that they looked back on the patient¿s report and it is definitely a cycling issue.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacture representative (rep) on 2018-feb-07.The rep stated that the cause of the cycling issue was that the cycling switch was accidently activated at the time of adaptive stimulation (as) set up.It appears to have been activated when the rep was assessing the energy usage to update the patient on the estimated recharge interval.The cycling function was switched off and stimulation resumed as prior.The issue has been resolved.The patient had been follow up with by the rep with no further issues to report.The information was confirmed with the physician.No further complications were reported/are anticipated.

• Brand Name: INTELLIS
• 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: 7244447
• MDR Text Key: 99787089
• Report Number: 3004209178-2018-02169
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169781702
• UDI-Public: 00643169781702
• 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
• Report Date: 02/27/2018

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: 10/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/07/2018
• Supplement Dates FDA Received: 02/27/2018
• Date Device Manufactured: 11/07/2017
• 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: 55 YR