MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Unintended Collision (1429); Delayed Charge Time (2586); Battery Problem (2885); Charging Problem (2892)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 97714, serial# (b)(4), implanted: (b)(6)2013, product type: implantable neurostimulator.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.

Event Description

Information was received from a consumer and a patient with an implantable neurostimulator (ins) for the treatment of failed back surgery syndrome and spinal pain.It was reported that the patient was taking a long time to charge (minimum 4-6 hours per device so up to 12 hours per day).The patient stated they had to charge more frequently and that they would have to charge 3 times a day.The patient stated they would start charging at 4am until 10am for the ins in their back and then would do their feet from 10am to 1pm.The patient would then have to go back to charging the back because the battery would have already depleted from full down to half.The patient stated the implant batteries seemed to be depleting more quickly.The patient reported no changes to programming or settings.It was reported the patient gets 6-8 coupling bars.The consumer stated the patient met with a manufacturer representative (rep) who showed the patient how to read the display on the recharger and made sure the patient was charging properly.The consumer stated the patient had an auto accident and had a couple fender benders in late 2016.The patient was redirected to their healthcare professional (hcp) to have the device checked.It was reviewed the patient could bring their recharger to check the statistics.The patient mentioned recharger and patient programmer issues that have all been previously documented.No further complications were reported/expected.Additional information was received from the rep on (b)(6)2017.The rep stated that they saw the patient before (b)(6) weekend.They met with the patient regarding rapid depletion and frequently recharging.The rep reported that they observed the patient's settings and noticed that they use all electrodes.Impedances appeared to be normal, so the rep didn't believe there was anything wrong with either battery.Rep does not recall anything regarding an auto accident being reported.The patient only has one recharger so they were going to request an additional recharger from the repair department.The issue was considered to be resolved at the time of the call.[refer to manufacturer report #3004209178-2017-14982 for details pertaining to the reportable related event.].

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that a manufacturer representative (rep) p resented to their office to interrogate the patient's device and troubleshoot.It was unknown if the charging issues had been resolved.The patient's weight at the time of the event was not obtained but vitals from their last visit were provided.[refer to manufacturer report #3004209178-2017-14982 for details pertaining to the reportable related event.].

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 6719416
• MDR Text Key: 80284689
• Report Number: 3004209178-2017-14984
• Device Sequence Number: 1
• Product Code: GZB
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Date Device Manufactured: 10/09/2013
• 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 Weight: 64