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

Model Number 97715

Device Problems Energy Output Problem (1431); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)

Patient Problem Insufficient Information (4580)

Event Date 04/20/2018

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 unknown indications for use.He reason for call was to know mri compatibility information.Pt reported that they haven't used the scs since about 6 months after implant, but before the ins went dead, they put the ins into "safe mode" (pss understood this to be mri-mode) and turned the ins off.Pt lost all of their equipment too.Pt explained that they stopped using the ins because about a week after implant , the stimulation level would "jump" anytime someone was around the pt with bluetooth (cellphone, etc.).Pt has ptsd, so they "can't do that" (pss understood this to mean that they cannot work with the therapy).Reviewed mri compatibility as it pertains to labeling.Pt stated that they are not turning the ins back on and they will get the ins removed.Redirected to the hcp.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue. pss reviewed the external device replacement process with the pt, but the pt declined any assistance with getting the external equipment replaced.Rep reported that cause was not known.They last saw the patient 2/28/19 and she had good coverage.

• Brand Name: INTELLIS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12032959
• MDR Text Key: 265883989
• Report Number: 3004209178-2021-09679
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Date Device Manufactured: 03/13/2018
• 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: 47 YR