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

Model Number 37714

Device Problems High impedance (1291); Device Difficult to Program or Calibrate (1496); Insufficient Information (3190)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37092, serial#: unknown, product type: accessory.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins).It was reported that the pad went out; patient clarified that he's having difficulty with the programmer antenna.Pt confirmed that the programmer powers on but that he can't use the programmer to make adjustments to the ins.Pss had the pt attempt communication to the ins with the programmer directly without the antenna and pt initially saw the poor communication screen, however after further guidance pt confirmed seeing the normal screen with his settings and noted that he was on group a.Pt confirmed that his stimulation was on and working.Pss then advised that the programmer antenna would be replaced and pss asked for the pt's delivery address, however pt became upset and stated he's having trouble with the ins and that he needs to have it checked.Patient was redirected to their hcp to have the ins checked.Pt became highly escalated; stated his hcp moved away so he doesn't have a current managing hcp.Patient mentioned their dissatisfaction.A new programmer antenna was sent to the patient.Later, a rep stated they were in contact with the patient and patient had not received the antenna as of (b)(6).It was noted patient should receive it by noon.No further complications were reported.On 2020-may-16, additional information was received from the rep.It was reported that the ins is working fine but high impedances >10,000 on all contacts on left lead except 14.Patient did not have an antenna for his remote but ordered from tech services.A delivery was confirmed.The cause of ins issues was high impedances on left lead.Patient was reprogrammed.The issue was resolved.Patient's weight was unknown.Patient's doctor had retired.The rep helped him get scheduled to see a new provider.The provided information was confirmed with the physician/account. no further complications were reported.

• Brand Name: RESTORE SENSOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10081862
• MDR Text Key: 191789809
• Report Number: 3004209178-2020-08996
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/22/2020
• Date Device Manufactured: 04/09/2013
• 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