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

Model Number 97715

Device Problems Device Or Device Fragments Location Unknown (2590); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, lot/serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead, ubd: 23-aug-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient's leads had been removed but the patient still had the ins in.The caller stated that they were supposed to have an mri for the patient, but the mri center told them that they cannot perform an mri with a partial system.The caller reported that the reason for calling was to know if the entire system needs to be removed before the patient could have an mri.It was reviewed that if the mri was a full-body mri, the device should be removed, and if the mri was head-only, then the hcp and mri center would need to determine the risk-to-benefit for the patient to have the mri done.Patient services requested that the caller get the controller out to check mri compatibility.The caller noted the patient's ins "hadn't been on forever".The caller reported that the controller kept saying no device found - reposition the recharger screen.The caller unconnected any cords attached but reported still seeing that screen.The caller performed a controller reset and reported that the controller needed to be charged.The caller connected the ac power supply into the controller and reported that they were now able to successfully navigate the home screen on the controller, and after clicking mri mode, they saw the screen telling them that the ins needed to be charged.The caller confirmed the mri was for the patient's back.The caller stated that they were told the ins was full-body eligible when it was implanted, since the patient would need an mri every year.It was reviewed that was no longer the case likely because the leads were removed.The caller became escalated and disconnected the call.No symptoms were reported.No further complications were reported.

• 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: 7642289
• MDR Text Key: 112488311
• Report Number: 3004209178-2018-14461
• 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: Other
• Type of Report: Initial
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Model Number: 97715
• Device Catalogue Number: 97715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2018
• Date Device Manufactured: 11/14/2017
• 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