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

Model Number 97715

Device Problems High impedance (1291); Labelling, Instructions for Use or Training Problem (1318); Energy Output Problem (1431); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 09/29/2018

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 patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain and failed back surgery syndrome.It was reported that patient was having troubles with her device she said she tried reading the instructions but she does not get it.The patient reported that there was a settings not available message.The patient reported that she tried to increase the setting.The patient didn¿t have additional groups to try.The patient noted that she was currently recharging the battery pack as that was low.The ins was at 60%.The patient was to charge the ins after charging the battery pack.The patient was to contact their healthcare provider (hcp) to schedule an appointment if she was still not able to adjust.The patient also reported a loss of therapy and return of pain.Additional information was received from a consumer via a manufacturer's representative.It was reported that the circumstances that led to the settings not available message, inability to increase, loss of therapy and return of pain was a change in device programming.The steps taken to resolve was that a rep met with the patient to change the settings.The unit was working fine.The patient has severe pain at location of "tens" unit implant.The patient reported that there was a return of severe pain at the location of implant.The rep reported that the patient was not getting stimulation as needed.The rep checked the patient's implant and electrodes 4 and 14 were high impedance.The current programming used both electrodes.The patient was reprogrammed around the electrodes and the patient reported getting good stimulation and relief.No further complications were reported or anticipated.

• 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: 8026008
• MDR Text Key: 126004880
• Report Number: 3004209178-2018-24378
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2018
• Date Device Manufactured: 08/13/2018
• 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: 53 YR