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

Model Number 97715

Device Problem Unintended Collision (1429)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 04/17/2019

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.The patient reported that he was experiencing pain below his ins implant site across the lower back.The patient reported that this was a sharp pain and that he didn¿t know if the pain was caused by the ins or his back.The patient reported that he already tried increasing the stimulation to 5.0 to help with the pain but had not been able to resolve the issue.The patient indicated that he wanted to try turning the ins off in the meantime to see if the sharp pain went away.The patient was assisted in turning the stimulation down and then off.The patient reported that this issue had been going on since he had a fall several months ago.The patient was redirected to follow up with their healthcare provider (hcp) to get the ins checked to confirm the fall didn¿t impact the ins and regarding the sharp pain if it didn¿t go away with the ins off.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient and a healthcare professional (hcp).The hcp suspected that the cause of the sharp pain was the patient's hip and the pain started after the fall.The patient was given a steroid pack.The patient stated they didn't know what the cause of the pain was and they just woke up with it.The patient stated they were prescribed a steroid for 6 days for the inflammation.The patient noted that the sharp pain had been resolved.No further complications were reported/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: 8811943
• MDR Text Key: 151737499
• Report Number: 3004209178-2019-13952
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2020
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Date Device Manufactured: 01/19/2019
• 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: 73 YR
• Patient Weight: 104