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 Break (1069); High impedance (1291); Battery Problem (2885); Connection Problem (2900); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 39565-65, serial# (b)(4), implanted: (b)(6) 2011, product type lead.Other relevant device(s) are: product id: 39565-65, serial/lot #: (b)(4), ubd: 11-oct-2014, udi#: (b)(4).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 an implantable neurostimulator (ins).It was reported that the rep met with patient for scheduled ins replacement due to normal battery depletion.Unable to check impedance pre op.Ins already dead.The healthcare provider (hcp) had difficulty removing lead from 0-7 channel on previous ins.Also, when we were removing leads from ins rep and hcp noted that paddle lead was connected incorrectly.0-7 was the right side of lead.They were able to remove 8-15 without difficulty.Hcp noted that the right lead was frayed between contacts at the connection site.They properly inserted the leads into appropriate channels.Connection check show 14-15 as red.Impedance check showed electrodes 10 and 15 as greater than 40000.The hcp wiped down contacts, and we were unable to get a better connection.In post anesthesia care unit (pacu), rep and hcp were able to get adequate coverage needed, and the pt is happy.The issue was resolved.No environmental issues were reported to have contributed to the event.The patient is alive with no injury.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11366529
• MDR Text Key: 244317930
• Report Number: 3004209178-2021-03076
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Date Device Manufactured: 06/22/2011
• 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: 63 YR