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

Model Number 37702

Device Problems Break (1069); Electromagnetic Interference (1194); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product id: 3708140; serial#: (b)(4); product type: extension.Product id: 3708140; serial#: (b)(4); product type: extension.Other relevant device(s) are: product id: 3708140, serial/lot #: (b)(4), ubd: 26-may-2015, udi#: (b)(4); product id: 3708140, serial/lot #: (b)(4), ubd: 04-oct-2014, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The manufacturer representative reported that on (b)(6) 2020, while still in a replacement case, the doctor had used cautery, which technical services (tss) believed was unipolar cautery.The lead or more likely the extension, had burned near the header.The rep had checked impedances in pre-op and the readings were normal.However, in when checked during the case, the impedances were out of range.The rep did not know what the exact readings were at the time of the call and they did not have time to provide additional information.Tss sent the rep information on cautery and follow up will be sent to the rep to obtain additional required information.No symptoms reported.The rep later reported that the ins was being replaced due to normal battery depletion on (b)(6) 2020.While replacing the ins, the cautery caused damage (the burn near the header) to the extension.Both extensions were replaced and explanted.The ins and extensions were discarded by the physician, so they were not going to be returned for analysis.The issue was reported to be resolved after the extensions were replaced.

• Brand Name: PRIMEADVANCED
• 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: 10980057
• MDR Text Key: 220709417
• Report Number: 3004209178-2020-21525
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2020
• Date Device Manufactured: 06/09/2011
• 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: 74 YR