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); Connection Problem (2900); Device Contamination with Chemical or Other Material (2944); Impedance Problem (2950)

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

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3708140, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Other relevant device(s) are: product id: 3708140, serial/lot #: (b)(4), ubd: 01-dec-2013, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

A manufacturer representative reported that the patient was undergoing an expected battery replacement.When pulling the extension out of the battery block, it was noted to have some debris on the contacts, making it difficult to remove from the block.Impedance checks were done. the impedances were off on most of the lead. the physician attempted to remove the substance that seemed to be attached to the wire around the contacts.He was unable to get the extension back into the block on the new battery. the physician decided to leave the lead out of the block.He capped it off and put a plug into the outlet.When the system was tested in pacu, all impedances on the remaining lead were good.The patient felt stimulation in her legs as before.

• 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: 11375187
• MDR Text Key: 243257356
• Report Number: 3004209178-2021-03193
• 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: 02/24/2021

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: 10/14/2010
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 02/24/2021
• Date Device Manufactured: 11/20/2009
• 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: 74 YR
• Patient Weight: 59