MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 37702

Device Problems Failure to Power Up (1476); Insufficient Information (3190)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 37743, serial# (b)(6), product type programmer, patient product id 37743, serial# (b)(6), product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 37743, serial/lot #: (b)(6), udi#: (b)(4) ; product id: 37743, serial/lot #: (b)(6), ubd: 13-jan-2016, udi#: (b)(4), b3: date is approximate.H3: analysis of the programmer (product id 37743, serial# (b)(6) was not preformed as they had adequate supplies of this m odel for replacement.Analysis of the programmer (product id 37743, serial# (b)(6), found no anomalies.This regulatory report is being submitted as part of a retrospective review as part of remediation plan 411.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Information was received from a patient (pt) who was implanted with an implantable neurostimulator (ins).It was reported that sometime around (b)(6) 2021 a picture of a doctor appeared on their programmer and they changed the batteries in their programmer and it worked.Pt stated that last night the programmer wouldn't power on at all.The caller was very difficult to understand.It was attempted to confirm an event date and pt stated they began having issues with the programmer sometime last week.An email was sent to the repair department to replace the programmer.No symptoms were reported.Additional information was received from a pt rep and it was reported that pt rep called back reporting replacement programmer screen will not power on, pt is using heavy duty batteries, pss redirect to replace with regular alkaline batteries and call back if further assistance is needed.Caller mentioned dr screen from previous call but did not know the code.Caller said that they received a replacement programmer in the mail, however the caller said, "he tried to cut it on and it's still not working".During the call, the connection was extremely poor so pss tried to call the pt rep back.When pss called pt rep back there was no answer.The patient returned the replacement programmer.Additional information was reported from the patient.They stated their issue resolved with putting new expensive batteries in it.No further complications were reported.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18956034
• MDR Text Key: 339152139
• Report Number: 3004209178-2024-07578
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2010
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2009
• 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
• Treatment: "SEE H11...."
• Patient Age: 60 YR
• Patient Sex: Male