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

Model Number 97702

Device Problems High impedance (1291); Migration or Expulsion of Device (1395); Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Discomfort (2330); Skin Tears (2516); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a290, serial#:(b)(4), implanted: (b)(6) 2020, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain and occipital neuralgia.It was reported that during the implant procedure, impedence of contact 0 was >10 ,000ohms.The rep re-checked impedences after closing and all were within normal range.In post-op the physician assistant found that the tuohy needle had punctured through the skin and was bleeding.The rep shared with both her and the hcp their concerns that the lead may have also punctured through the skin and was therefore contaminated and should be removed.They both declined removal of the implant and proceeded to treat the skin puncture and gave the patient an extra dose of iv antibiotics prior to sending them home.No patient complications were reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received and patient stated that they had a red sore on their scalp over the area where her lead ends.They stated the sore is not open and stings periodically.Patient noted they were not concerned but is starting her on oral antibiotics.No further complications noted or anticipated.

Manufacturer Narrative

Continuation of d10: product id 977a290 lot# (b)(6) implanted: (b)(6) 2020 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.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.

Event Description

Hcp notified rep that patient is scheduled for lead revision and battery replacement.Hcp reports occipital lead shifted as a result of a recent massage and patient also complains about size and location of current prime cell.Plan is to reposition the occipital lead and replace with smaller ins/reposition ipg to subclavicular pocket on (b)(6).

Manufacturer Narrative

Continuation of d10: product id 977a290, serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2021, 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.

Event Description

Rep responded from follow up sent.Lead repositioned/replaced and ins replaced with intellis and pocket moved to more comfortable position.Device will not be returned for analysis as customer discarded.

• 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: 10254232
• MDR Text Key: 198331241
• Report Number: 3004209178-2020-11908
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169974883
• UDI-Public: 00643169974883
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR