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

Model Number 37702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Unspecified Infection (1930); Pain (1994); Complaint, Ill-Defined (2331); Injury (2348); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)

Event Date 05/01/2015

Event Type  Injury  

Manufacturer Narrative

Date of event was reported as (b)(6) 2015.

Event Description

Information received from the patient reported that they were burned "on several occasions" with the worst burn by radio frequency (rf) ablation in (b)(6) 2015 and again on (b)(6) 2016.They received first, second, and third degree burns on several occasions.It was noted that the manufacturer's representative was present in 2015 when they were burned rf ablation.The patient did not clarify how their implantable neurostimulator (ins) was related to the burns.Additional information received from the patient via the manufacturer's representative reported that they had a rhizotomy in (b)(6) 2015 and has some burns.The representative knew nothing about this and, in their opinion, was not related to the ins.The patient had the rhizotomy from one doctor and they went to another doctor where they were seen just to reprogram them.The indications for use for the implanted device were noted as non-malignant pain and cervical radiculopathy.

Event Description

Additional information received from the patient via the manufacturer's representative reported that they had a rhizotomy in (b)(6) 2015 and has some burns.The representative knew nothing about this and, in their opinion, was not related to the ins.The patient had the rhizotomy from one doctor and they went to another doctor where they were seen just to reprogram them.There was a report that the patient had been receiving radio frequency ablation procedures since approximately the end of 2009.In 2015, they received first and second degree burns after a rf ablation procedure.They received burns multiple times after this and altogether, they received first, second, and third degree burns on their upper back, lower back, shoulder, and buttocks.The burns were described as deep wounds, throbbing pain, and missing skin at the site.It was reported that they saw a wound care specialist for months to treat their burns and was told they tested positive for an infection.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5928535
• MDR Text Key: 53923657
• Report Number: 3004209178-2016-18250
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2013
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2016
• Date Device Manufactured: 10/26/2011
• 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 Outcome(s): Other
• Patient Age: 47 YR