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

Model Number 37702

Device Problems Electromagnetic Interference (1194); Insufficient Information (3190)

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

Event Date 01/01/2008

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3998 lot#: v062321, implanted: (b)(6) 2008, product type: lead.Other relevant device(s) are: product id: 3998, serial/lot #: (b)(4), ubd: 12-oct-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that in 2008, they had electrocautery done, which resulted in the ins and the leads getting burnt.They explained that they had forgotten to turn off the ins before the electrocautery was performed.No symptoms were reported.

• 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: 10701376
• MDR Text Key: 219515873
• Report Number: 3004209178-2020-18234
• 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: 10/19/2020

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: 05/28/2008
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/19/2020
• Date Device Manufactured: 12/05/2006
• 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: 58 YR