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); Migration or Expulsion of Device (1395); Appropriate Term/Code Not Available (3191)

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

Event Date 07/14/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, lot/serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 977a260, lot/serial#: (b)(4), implanted: (b)(6) 2018, product type: lead.Product id: 977a260, serial/lot #: (b)(4), ubd: 07-jun-2022, udi#: (b)(4).Product id: 977a260, serial/lot #: (b)(4), ubd: 07-jun-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a manufacturer's representative (rep) regarding an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient said their stimulation shifted from left to right and then they couldn't feel it, so a reprogramming was scheduled.The patient stated that they were not doing anything crazy as far as bending lifting or twisting.The patient presented at the reprogramming and all impedances were green and less than 900.The patient could feel stimulation when the left lead was turned up, but felt nothing when the right lead was turned up.The rep changed the pulse width and rate and ran up amplitude, but nothing was felt.The healthcare provider (hcp) brought the patient back for a fluoroscopy shot and it was noted the lead was pulled down and out of the epidural space based on location in ap.No intervention has occurred yet, but the plan seems to be to refer out for a paddle lead replacement.No further complications were reported or anticipated.

Manufacturer Narrative

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

• 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: 7721982
• MDR Text Key: 115088080
• Report Number: 3004209178-2018-16677
• 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: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• 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: 08/08/2018
• Date Device Manufactured: 03/10/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 91