MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS

Model Number 97715

Device Problems Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Charging Problem (2892); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2018

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 consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported the patient had trouble with controller, the patient had an error screen ¿cannot continue ¿ call manufacturer¿.Patient stated she could not charge.It was noted it took patient over 4 hours at times to charge her ins since implant on (b)(6) 2018.Patient saw ¿excellent¿ for coupling to ins during recharge, the controller didn¿t give a little tweet sound when charge was completed since 1-week post implant (b)(6) 2018.Patient could not increase her setting since weeks ago, 2018.Patient experienced settings not available screen when she tried to increase stimulation today on (b)(6) 2018.It was documented that patient¿s issue had seemed intermittent.Troubleshooting included patient services had patient connected to verify the charge speed patient was set on, patient stated she was set to ¿4¿, and tried to increase stimulation while on the call and saw ¿settings not available¿ screen.It was noted the patient was unable to increase with controller for the last few weeks, it used to give a sound to let her know the charge was completed.No further complication and no symptoms were reported.

Manufacturer Narrative

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

• Brand Name: INTELLIS
• 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: 7643178
• MDR Text Key: 112616358
• Report Number: 3004209178-2018-14491
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2018
• Date Device Manufactured: 04/02/2018
• 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: 60 YR