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

Model Number 97715

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97745 ; serial# unknown, product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient was implanted on (b)(6).Pt has been in excruciating pain ever since he woke up from the surgery.He had the worst pain when he came out of operating room that he ever had in his life.Hcp has been giving him some pain pills.Hcp said pt is through with pills.Pt saw the rep on (b)(6)to have his device programmed.Every time she set a mode pt was telling her it was stimulating his l hip and thigh.Every change was the same.The rep was not able to get the device to stimulate his back.His pain is in his back and he needs stim in his back.Pt went to er on (b)(6) and they gave him some relief to kill the pain.Pt had an apt with a rep yesterday but they texted and said something came up and he could not meet.Pt called rep and told him it was a bad day and next week pt is going to the mountains which will be another week of pain with no pain pills.Pt says they do not realize what pain he is in.The device costed him so much and he gets no relief.Pt is leaving to go to the mountains tomorrow and asking if there is a rep who could meet him there.Rep emailed the cause was not determined.The patient left town.The rep was to meet with the patient on (b)(6) 2020 when he returned.Rep relied from follow up sent.Rep reported root cause was not determined.Actions taken to resolve issue was reprogram.Issue has not been resolved, patient is consulting with physician.Patient called and reported the implant was explanted.Patient does not have the implant any longer.Implant was removed.

• 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: 12301393
• MDR Text Key: 265824966
• Report Number: 3004209178-2021-12159
• 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: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Date Device Manufactured: 04/14/2020
• 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: 68 YR