MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97712

Device Problem Overheating of Device (1437)

Patient Problems Unspecified Infection (1930); Pain (1994); Burning Sensation (2146); Skin Inflammation (2443)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3889-33, lot# 0213243456, implanted: (b)(6) 2017, product type: lead; product id: 3889-28, lot# 0214304776, implanted: (b)(6) 2017, product type: lead; product id: 3889-33, lot# 0213279715, implanted: (b)(6) 2017, product type: lead; product id: 37082-20, serial# (b)(4), implanted: (b)(6) 2017, product type: extension; product id: 37083-20, serial# (b)(4), implanted: (b)(6) 2017, product type: extension; product id: 3889-28 lot# 0213632497, implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information received from a healthcare professional (hcp) via a manufacturer representative that a consumer complained of burning pain, lower buttock area, when charging the implantable neurostimulator (ins).No pain when not charging device.It was noted that since implant, three blister-like sores have occurred lower buttock.No factors noted to have led to the event.The ins was turned off on consumer reporting the issue.An mri was organized b the hcp, and the mri did not report any issues surrounding implant or with implant placement.Actions planned were noted as will be talking with consumer and turning one lead on at a time and charging device to investigate if the consumer felt any discomfort when a particular lead is turned on/off.The issue was not resolved at the time of the report.There were no further complications reported and/or anticipated.

Manufacturer Narrative

Continuation of d11: product id 3889-33 lot# 0213243456 implanted: (b)(6)2017 product type lead product id 3889-28 lot# 0214304776 implanted: (b)(4)2017 product type lead product id 3889-33 lot# 0213279715 serial# implanted: 2017-12-12 explanted: product type lead product id 37082-20 (b)(4) implanted: (b)(6)2017 product type extension product id 37083-20 (b)(4) implanted: (b)(6)2017 product type extension product id 3889-28 lot# 0213632497 implanted: (b)(6)2017 product type lead if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) via the rep indicated that the patient was implanted for pain and incontinence, and was not considered an off-label use.They were not aware of the patient charging under their clothes/blanket in regards to factors that contributed to the event.The cause of the burning pain was an infection.This was determined by the clinician.It was noted that three leads and the ins were removed.There were no further complications reported as a result of this event.

Manufacturer Narrative

Product id (b)(4) lot# 0213243456 implanted: (b)(4) 2017 :product type lead: product id (b)(4) lot# 0214304776 implanted: (b)(4) 2017: product type lead product id (b)(4) lot# 0213279715 implanted: (b)(4) 2017: product type lead product id (b)(4) serial (b)(4) implanted: (b)(4) 2017 product type extension: product id (b)(4) serial (b)(4) implanted: (b)(4) 2017: product type extension product id (b)(4) lot# 0213632497 implanted: (b)(4) 2017: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative (rep) indicated that the surgeon reported that the infection was at the ins site.There were no further complications reported as a result of this event.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7436046
• MDR Text Key: 106163303
• Report Number: 3004209178-2018-08150
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Date Device Manufactured: 03/01/2017
• 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): Required Intervention
• Patient Age: 46 YR