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

Model Number 37712

Device Problems Energy Output Problem (1431); Data Problem (3196)

Patient Problem Pain (1994)

Event Date 01/11/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_ptm_prog, serial# unknown, product type: programmer.Patient product id: a71100, serial# unknown, product type: software.Other relevant device(s) are: product id: neu_ptm_prog, serial/lot #: unknown, product id: a71100, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer concerning patient with an implantable neurostimulator (ins).It was reported that the patient programmer showed the ins in the box message.Patient reported that he got programmed by manufacturer representative (rep) about a month ago and ever since then his patient programmer didn't work because all it would show is the ins in the box message.It was reviewed that this message can be resolved with a physician programmer session.Patient said that his insr works fine and he is able to use insr to charge ins and turn stimulation up or down but isn't able to adjust his stimulation and wishes he could because he got device for pain so he is always in pain but it seems like today his back started hurting more than usual.The patient was redirected to their healthcare provider (hcp).No further complications were reported/anticipated.

• 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: 9764259
• MDR Text Key: 183777850
• Report Number: 3004209178-2020-04202
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Date Device Manufactured: 07/28/2011
• 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: 51 YR