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

Model Number 97714

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 06/10/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical product: product id: 97754, serial# (b)(4), product type: recharger.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.The patient reported that they were charging yesterday, and it automatically turned their stimulation on.The patient stated they th ought maybe they bumped the buttons.They stated that they shut stimulation back off and then 10 to 15 minutes later it turned the stimulation back on again.The patient grabbed the recharger and shut their stimulation back off and the screen went blank.From that point on, the recharger had not function.The recharger showed nothing on the screen.The recharger was not beeping.The desktop charger had the green light on and the connector pin looked fine.Patient services walked the patient through resetting the recharger on the call.The patient did a reset and it resolved the blank screen.The patient confirmed the recharger was now working and taking a charge.It was reported that the issue of the patient charging their ins and it automatically turning stimulation on, shutting stimulation off and it turning back on 10 to 15 minutes later occurred on (b)(6) 2018.It was indicated that this was considered to be a sudden change in therapy/symptoms.The recharger screen going blank also occurred yesterday on (b)(6) 2018 and this issue was resolved on the call.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: 7603621
• MDR Text Key: 111152397
• Report Number: 3004209178-2018-13489
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

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: 12/28/2017
• 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: 06/11/2018
• Initial Date FDA Received: 06/14/2018
• Date Device Manufactured: 02/08/2017
• 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: 38 YR