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); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 3888-33, lot# v012744, implanted: (b)(6) 2006, product type lead.Product id 3487a-33, lot# v013052, product type lead.Information references the main component of the system.Other relevant device(s) are: product id: 3888-33, serial/lot #: (b)(4), ubd: 25-sep-2010, udi#: (b)(4); product id: 3487a-33, serial/lot #: (b)(4), ubd: 02-oct-2010, udi#: (b)(4).Reflects the other applicable components codes.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation - nonmalignant pain.It was reported that the patient had her routine implantable pulse generator (ipg) replacement on (b)(6) 2018.Patient was told not to use the ipg until she saw her healthcare provider on (b)(6) 18 for dressing change and to ensure incision at the ipg pocket was healing well.The patient state she had seen her hcp and had started using her ipg.Patient stated her stimulation was spotty and could not get it strong enough unless she arched her back.Reprogramming was discussed with the patient.Patient reported she would see her pain doctor on (b)(6).On (b)(6), the manufacturer's representative spoke with pain fellow regarding patient and current poor stim coverage.Fellow stated that the next step for her would be a lead revision.No known environmental factors were reported.The ipg is to be reprogrammed to try and get better stim coverage.Issue is not resolved at time of report.Surgical intervention is unknown at this time.No further complications were reported/anticipated.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer's representative.It was reported that the hcp determined the patient need ed new leads to cover her existing pain.Current lead is a 2x4 paddle; they were going to attempt to do surgery before her insurance changes.No surgery date confirmed at this time.

Manufacturer Narrative

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: 7646206
• MDR Text Key: 112854611
• Report Number: 3004209178-2018-14565
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Device Lot Number: V013052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 05/30/2018
• 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: 35 YR