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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Muscle Weakness (1967); Ambulation Difficulties (2544)

Event Date 02/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the reason for the call was to contact a manufacturer representative (rep).They had an appointment coming up with their healthcare provider for reprogramming.They state they had a terrifying experience a month ago.No further information was provided as the caller disconnected the call.Additional information was received from the patient and healthcare provider (hcp).The patient stated that they have been having instances where it feels like they have had a ¿loss of limbs¿ or leg weakness and is unable to stand up.They noted that this issue began on (b)(6) 2020.The patient stated that they had met with a manufacturing representative (rep) prior to the issue, and the implant had been turned off and was only doing pain management for 29% of the time.The patient noted that after reprogramming, their legs felt more grounded, but there were certain positions where they would have to adjust the stimulation.They then stated that on (b)(6) 2020, they had another incident where they had a fall.They noted that their programmer was next to their chair and they were able to get themselves in their chair and turn the implant off.The patient added that it took 45 minutes to regain feeling in their legs.They wanted to know if it is possible that their device is malfunctioning due to having these falls.They stated that when the rep had reprogrammed them, they indicated that everything looked fine and that the implant was functioning as intended.The hcp noted that the patient has a follow-up appointment on (b)(6) 2020 and will leave the appointment as is due to the covid-19 crisis.No further complications were reported or anticipated.Additional information received from a manufacturer representative (rep).It was reported that the hcp called the rep to discuss the lost feeling in the patient's leg.The hcp requested imaging, but there were no results yet.Impedances were within the 800-1000 ohms range.No further complications were reported.Additional information was received from the rep and it was reported that the rep is on site for revision surgery today.Hcp will be replacing patient's percutaneous leads with a surgical paddle and replace the neurostimulator.Patient shut of therapy last year because stimulation caused numbness in her legs.Rep is waiting for patient's handset for interstim to charge up before she can turn therapy off to allow scs surgery.

Event Description

Additional information was received.It was reported the device was thrown away by the hospital.It was noted the patient was very happy and they were doing much better and slept well.

Manufacturer Narrative

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: 10986216
• MDR Text Key: 220955026
• Report Number: 3004209178-2020-21621
• 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
• Report Date: 12/11/2020

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: 02/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR