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

Model Number 97715

Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Nerve Damage (1979); Neuropathy (1983); Pain (1994); Therapeutic Effects, Unexpected (2099); Weakness (2145)

Event Date 05/01/2018

Event Type  Injury  

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 an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was implanted for back pain.They were only receiving stimulation on their left side but not on the right.The patient met with a representative who reprogrammed the patient and "bumped it up" before backing the stimulation down to 2.4 or 2.8.After this adjustment, the patient experienced pain from their calf muscles to their feet.Their joints and back hurt and they experienced pain in their shoulder and elbow joints.The patient also experienced weakness in both arms.They backed the stimulation down to 0.2 for both p1 and p2 but didn't receive much relief from these issues.The patient then turned their stimulation off completely and has since seen a gradual improvement in their issues.They still had some pain but it was much improved since turning the stimulation off.The patient believed that when the representative reprogrammed them, the stimulation started radiating up their spine to off-target locations.They believed that caused nerve damage that they were starting to recover from.The patient had an appointment with their healthcare provider next week to address the issues.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from the representative.It was reported that they met with the patient on (b)(6) 2018.The patient believed their joint pain was getting better and that they believe they were getting some back pain relief from their stimulation.They performed some reprogramming with the patient.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information received from the representative.It was reported that the representative called the patient on (b)(6) 2018 and they mentioned they were getting some relief from their new programming.The patient also mentioned they had some calf neuropathy.The representative programmed a b program during their previous session and advised them to try that prior to their follow up appointment.The patient texted the representative and said they were seeing a great improvement.When they met with the patient on (b)(6) 2018 they noted that the patient hadn't actually switched to program b and that they were receiving the great improvement from the a program.Their joint pain was even better and the calf neuropathy was noted/discussed with the healthcare provider.Both the healthcare provider and patient were happy with the pain relief from the stimulator.No further complications reported.

• 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: 7552664
• MDR Text Key: 109504726
• Report Number: 3004209178-2018-12094
• 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,Followup
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2018
• Date Device Manufactured: 03/02/2018
• 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: 77 YR