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

Model Number 97714

Device Problems Break (1069); High impedance (1291); Device Operates Differently Than Expected (2913); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 06/28/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received via a manufacturer representative from a consumer regarding a patient who was implanted with a neurostimulator.It was reported that the patient felt that his device was not working correctly.The patient met with a manufacturer representative who interrogated the device and ran an impedance check.The patient¿s device shows all electrodes out of range.There were no environmental, external, or patient factors reported which may have led or contributed to the issue.An x-ray was taken of the leads and the battery site which showed no migration.The patient has been scheduled in (b)(6) 2018 for a revision; however, the exact date is unknown at this time.The issue was not resolved at the time of the report.There were no further complications reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the affected leads were sent to the manufacturer for analysis.No further complications are anticipated.

Manufacturer Narrative

Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer¿s representative (rep).The rep reported that the patient was currently undergoing a full revision.The rep reported that the reason for the revision was due to the patient reported the neurostimulator (ins) was no longer working and a loss of coverage was experienced.The rep also reported that the patient didn't charge the device and didn't know the reason.The rep reported that while intra-operative impedance testing was done at the pocket site and impedances were all over 40,000 ohms when testing with an external neurostimulator (ens).The rep tried again after removing, wiping down and reinserting the leads with similar results.The rep reported that at this point the healthcare provider (hcp) decided to replace both leads.The rep reported that one lead was explanted successfully and the other was accidentally cut above the anchor with the lead in the epidural space.No further complications were reported.

Manufacturer Narrative

Analysis of the implantable neurostimulator found no significant anomalies.Analysis of the leads found that the conductors were broken at the anchor site.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: analysis results were not available as of the date of this report.A follow-up will be submitted when analysis is complete.H6: conclusion code 67, method code 4114, and result code 3221 no longer apply.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 7654754
• MDR Text Key: 112871820
• Report Number: 3004209178-2018-14751
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Date Manufacturer Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR