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

Model Number 97715

Device Problems Energy Output To Patient Tissue Incorrect (1209); Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 05/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for chronic pain.It was reported that was implanted with one intrathecal baclofen pump and two spinal cord stimulators.Patient began to feel shivering inside the body (a feeling that as if stimulation was being delivered from inside the body) from one day.This state was not improved even though stimulation of the spinal cord stimulator was turned to 0ma/off.One of the ins was set to 1,000 hz and the other was 20 hz.When 1,000 hz was changed to 20 hz in the condition of 0ma, the patient complained of a tightness in the chest.The setting was therefore returned to 1,000 hz; the symptoms was improved.The setting of the other ins was changed to 1 ,000 hz from 20 hz next; the patient said that the condition got better.In addition, medication was given.The physician could not decide about causality and might be considering that the event was due to the product.No further complications were reported as a result of this event.

• 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: 7570706
• MDR Text Key: 110128312
• Report Number: 3004209178-2018-12646
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• 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: 12/28/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/15/2018
• Initial Date FDA Received: 06/05/2018
• Date Device Manufactured: 01/04/2018
• 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: 66 YR