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

Model Number 97715

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 04/01/2021

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 spinal pain. The patient reported that they thought that the implantable neurostimulator may have moved inside some muscle. The patient said they were at their physical therapy appointment and the therapist used a big ball on their back over the ins (therapist didn't realize that was where the ins was). Pt said the therapist was pushing pretty hard with the ball over the ins, which hurt, and pt said that was the only thing they could think of that could have moved the ins. Event date was asked, but pt said it was when they started therapy, and said they had been in therapy for 3 months, but later said it was probably around (b)6). 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
• 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: 12031388
• MDR Text Key: 257162606
• Report Number: 3004209178-2021-09652
• Device Sequence Number: 1
• Product Code: LGW
• 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: 06/21/2021

1 Device was Involved in the Event

0 Patients were 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

• Device Expiration Date: 10/28/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial