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

Model Number 97715

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

Patient Problems Bruise/Contusion (1754); Pain (1994); Discomfort (2330); Ambulation Difficulties (2544); Swelling/ Edema (4577)

Event Date 11/14/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a patient (pt) regarding an implantable neurostimulator (ins).The reason for call was pt reports the ins slipped out of the pocket mid (b)(6) probably around the (b)(6).Pt saw dr on (b)(6) and they were in agony and couldn't stand or sit.Hcp initially scheduled a revision for (b)(6), but dr had to postpone due to contracting covid.Pt went in for the procedure to move ins on (b)(6), and a rep was present.Pt informed rep of the issue.Pt's last recharge was the night before, then ins was turned off.Pt was informed ins could be turned back on friday (b)(6).However pt was feeling sore and only tried using recharger last night.Pt noted being sore, swollen and black and blue after the procedure(left side) no bandage present.Last night pt connected with controller only to see ins battery 50%, once recharger was connected pt was seeing no device found and al screen.Pt called rep today to discuss recharging issue and tried resetting controller times.Pt reports seeing no device found.Pt services (pss) reviewed considerations for charging over an unhealed wound.Pss reviewed impact of recharger placement and distance caused by swelling.Pt will wait until follow up appt next tuesday to try recharging and call back if assistance is needed.During the call pss reviewed how to reposition antenna.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11214345
• MDR Text Key: 228181929
• Report Number: 3004209178-2021-01177
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 01/22/2021
• Date Device Manufactured: 08/25/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 58 YR