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); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Battery Problem (2885)

Patient Problems Neurological Deficit/Dysfunction (1982); Seizures (2063)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins).It was reported that the patient was having seizures while using their ins.The patient let their ins go into overdischarge and the seizures stopped.Several attempts were made by the patient¿s healthcare provider (hcp) to resolve the issue, but they were unsuccessful.The patient plans to have the ins explanted in the near future.No further complications are anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2019-, product type: lead.Analysis of the implantable neurostimulator and lead have not yet begun.A follow up report will be submitted once analysis is completed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of product id# 97714 found stim ins/battery/reduced capacity due to overdischarge.Analysis of product id: 39565-65 found no significant anomaly.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported that the patient's ins was explanted yesterday ((b)(6) 2019) and it was discovered that about one inch of the sheath covering the lead was gone and leaving exposed wires (right below the paddle lead).It was noted that this was causing the patient to have involuntary body movements not seizures.The rep wanted to add that the patient's ins was implanted deeper than it needed to and was literally right up next to the bone.No further information was reported.

Manufacturer Narrative

Concomitant medical products: product id 39565-65 lot# serial# (b)(4) implanted: (b)(6) 2010 explanted: (b)(6) 2019 product type lead.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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: 8222701
• MDR Text Key: 132244705
• Report Number: 3004209178-2019-00382
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/07/2019
• Supplement Dates Manufacturer Received: 01/07/2019; 08/06/2019; 08/06/2019; 12/18/2019
• Supplement Dates FDA Received: 01/18/2019; 08/08/2019; 08/21/2019; 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 52