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

Model Number 97715

Device Problem Overheating of Device (1437)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Burning Sensation (2146); Discomfort (2330); Skin Inflammation (2443)

Event Date 08/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The manufacturer representative reported that two minutes into recharging the patient experienced discomfort, hot and burning sensation at the pocket.It was noted that the patient recently had surgery and the healthcare provider indicated the wound looked appropriate.The wound was described as red with bruises and some blisters and the patient was not placing the antenna directly over the skin.The current recharge speed was set to excellent coupling and troubleshooting reduced the speed to low until the wound fully healed.The patient was on low density settings with low intensity and the charge duration was about every 20 days.The indication for use was spinal pain.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that the cause of the burning at the pocket was unknown.It was believed that they were just sensitive to heat from the recharger after implant.The patient is able to charge now without problems and id no longer having burning sensation.The actions taken to resolve the burning at the pocket site was that the rep met with the patient on 8/31.The rep stated that they had called technical services and adjusted the recharging speed from the highest at 4 to the second at a 2.The patient didn't feel the burning sensation at the lower speed and they waited for the battery to be completely full.The patient didn't need to recharge for approximately 15 days on their settings.The burning sensation has been resolved.The rep was at a follow-up appointment on 9/25, the patient is charging on the highest level of 4 without any problems.The patient was educated on how to change the settings as well.The information was confirmed with the physician.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: 7842107
• MDR Text Key: 120131514
• Report Number: 3004209178-2018-19773
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2018
• Date Device Manufactured: 07/17/2018
• 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: 52 YR