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

Model Number 97715

Device Problems Use of Device Problem (1670); Malposition of Device (2616); Battery Problem (2885); Charging Problem (2892)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Seroma (2069)

Event Date 05/14/2019

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 consumer, via a manufacturer representative (rep), regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient had pain at the ins battery site and difficulty charging.The rep said they palpated the site and the ins moved slightly but was nothing of concern.The patient continued to have a lot of muscle spasms and pain at the ins battery site.The rep said the patient was also struggling a little bit with the charging; the rep believed this was due to fluid in the pocket.The healthcare professional put the patient on some new medication for the muscle spasms in their neck.The rep said that other than that the patient had good coverage and said the system was working.The ins was activated and adjusted.The patient reported that due to where the ins was located in their upper buttock, the recharger was difficult to keep in place.The patient said "i have to sit perfectly still to get good contact and the belt doesn't work".The patient also mentioned that they noticed the ins "runs down fairly quickly" stating they had to charge the ins every 3 days.Adhesive discs were ordered and sent to the patient per their request.It was noted that the issue was not resolved at the time of the report.No further complications were reported.

Manufacturer Narrative

Review of this mdr and/or additional information received shows that there is no evidence to reasonably suggest that the device in this report may has malfunctioned and that the device or a similar device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.Medtronic is submitting this report to comply with fda reporting.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: 8716558
• MDR Text Key: 148818817
• Report Number: 3004209178-2019-11966
• 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,Followup
• Report Date: 07/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Date Device Manufactured: 12/06/2018
• 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: 48 YR