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

Model Number 97714

Device Problem Disconnection (1171)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977c165, 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

On (b)(6) 2020, the patient reported that their wires are like ¿theft¿ and there is a big bump.They noted that they are looking for a physician.Physician listings were sent to the patient.The patient was redirected to follow-up with their healthcare provider.On 2020-july-20, additional information was received from the patient reporting that they had ¿two wires that had fallen off¿.They clarified this by saying that the leads were disconnected since two years ago.The patient stated that they had never had this much pain in their life.They stated that the pain was down their leg and into their foot and they could not stand on the left foot since a year ago.They stated that they wished they would have never gotten the pain stim device implanted and they did not have a current managing healthcare provider (hcp).

Manufacturer Narrative

Continuation of d11: product id 977c165, serial# (b)(6), implanted: 2017-01-24, 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

Additional information was received from the patient.Patient reported that the issue with the wire being like "theft" was first observed over a year ago, maybe 2.There were no circumstances that led to the issues.

• 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: 10305699
• MDR Text Key: 199831021
• Report Number: 3004209178-2020-12574
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."
• Patient Weight: 56