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

Model Number 97714

Device Problems Electromagnetic Interference (1194); Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Pain (1994); Tingling (2171); Therapeutic Response, Decreased (2271); Discomfort (2330)

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for cervical radiculopathy and spinal pain.The patient stated that they have their stimulator for their complex regional pain syndrome/rsd in their right hand.The patient had an mri on (b)(6) 2018 and during the mri they experienced a tingling in their right hand.The mri technician was there to confirm that they placed the device into mri mode.The patient saw the full body eligible screen on the patient programmer that confirmed the stimulation was turned off.The patient stated that they had one more test that the technician had to do and while they were in the mri machine tube they began feeling the tingling in their right hand similar to the tingling they experience from the ¿unit¿ (stimulator).The patient thought this was very unusual.The tingling happened once and they said ¿that was odd¿ but didn't say anything at first but then the tingling happened again so they stopped and aborted the mri session.The patient turned the stimulation back on after the procedure but they were uncomfortable so they have the stimulator off right now.The patient increased the stimulation when they were using the patient programmer to put it into mri mode from the mri procedure.The patient noticed a return of symptoms now that the stimulator is turned off.The patient was redirected to follow up with their healthcare professional (hcp).They noted having an appointment tomorrow.No further complications were reported/are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep).It was reported that since the mri scan, the patient had not had any changes in their stimulation and no new symptoms.The rep said that the patient felt baseline pain with the stimulation off, as expected.The patient noted that they had had a prior mri of their wrist with their current system configuration and nothing happened with that scan at all.No further complications were reported/are anticipated.

• 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: 7389178
• MDR Text Key: 104159219
• Report Number: 3004209178-2018-06222
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

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: 07/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2018
• Initial Date FDA Received: 04/02/2018
• Supplement Dates Manufacturer Received: 04/02/2018
• Supplement Dates FDA Received: 04/06/2018
• Date Device Manufactured: 09/03/2015
• 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: 59 YR