MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE ULTRA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37712

Device Problem Data Problem (3196)

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

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37743, serial#: (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative, regarding a patient who was implanted with a neurostimulator (ins) for lumbar radiculopathy.It was reported that the patient controller displayed the ins in the box message at the appointment today ((b)(6) 2019.The caller had used the new clinician tablet application to communicate with the ins prior to calling.Rep was asked to interrogate with the old clinician programmer.The caller then ended the session and then interrogated with the new clinician tablet application, ended the session and again checked the ins using the patient controller and confirmed that she was able to interrogate the ins normally.No symptoms were reported and no further complications were reported.

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 9364019
• MDR Text Key: 176319204
• Report Number: 3004209178-2019-22428
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2011
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2019
• Date Device Manufactured: 11/24/2010
• 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: 41 YR