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); Unable to Obtain Readings (1516)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from patient, via manufacturer representative, concerning patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that there was an impedance issue.The representative was seeing the patient for reprogramming.The representative requested information on how to perform re-orientation.The patient was feeling stimulation.The representative reported that when she performed electrode impedance, all contact pairs except for electrode 13 were showing xxx.Electrode 13 showed normal impedance.No messages were seen when interrogated with clinician programmer.The representative reported that the patient had an mri scan recently and placed the device into mri mode.The mri scan was unrelated to patient¿s device/therapy.Troubleshooting could not be performed due to lack of access to the product, as the patient did not have the recharger with her at the time of the appointment and no recharger was available.No patient symptoms were reported.No further complications were reported/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 on 04/18/2018.It was reported that the reprogramming was due to the patient having new pain.There was no device or procedure issue.No troubleshooting was performed because they did not have the recharger.No actions had been taken to resolve the impedance issue and the cause was unknown.The patient¿s weight was unknown.It was subsequently reported that the representative was with the patient to test impedances to see if the xxx appeared.The caller was informed that xxx is often just temporary interference.The representative tested the impedances at.7v and the ins generated results and there was no xxx.No further complications were reported/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: 7441736
• MDR Text Key: 106144556
• Report Number: 3004209178-2018-08355
• 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: 05/03/2018

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: 03/28/2017
• 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: 04/17/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 05/03/2018
• Date Device Manufactured: 05/09/2016
• 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: 43 YR