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 Nerve Damage (1979); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 07/01/2018

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 patient and healthcare provider (hcp) regarding the patient's implantable neurostimulator (ins) for occipital neuralgia and spinal pain.Information was reported that the patient is getting an mri due to having a lot of balances problems.They are checking to see if there was any nerve damage that could have occurred during the implant of the device.It was reported that the spinal cord stimulator (scs) mri labeling is confusing because the mri tech doesn't know if she is full-body eligible.It was reviewed that eligibility must be determined by the patient programmer (pp).The patient stated that she may have nerve damage that happened from the implant of her ins.The patient stated she has had balance problems for a few months now and it is getting worse in the past month.The caller was redirected to follow up with their healthcare provider (hcp), and the patient reported that they may have the ins taken out.The change in symptoms were considered gradual.No further complications were reported.No additional patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer on (b)(4) 2018 reporting that the cause of the issue was unknown.It was thought to potentially be a pinched nerve from implant.Stimulation had been turned off and an mri had been performed.The mri results were unknown at the time of the report.The patient found that they could now use the bathroom properly.They still had balance problems and brain problems reported to be thought, cognition, balance, and confusion.Stimulation was still off.Patient was reported to have started at (b)(6) and currently be at (b)(6) lbs.No further complications were reported.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8005756
• MDR Text Key: 125021890
• Report Number: 3004209178-2018-23916
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Date Device Manufactured: 12/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 93