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

Model Number 97714

Device Problems Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Charging Problem (2892)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 2018-may-14, information was received from a patient regarding their neurostimulator (ins) that was implanted for non-malignant pain.It was reported that the therapy had stopped due to power on reset (por).Patient was using her patient programmer (pp) when the event occurred.Patient stated that their ins had not been charged for a while because she was in hospital for unrelated reasons.A couple of weeks prior to the date of report, patient realized it was not working at all and she could not charge.Patient notified the rep and met with him on (b)(6) 2018.Rep got the device to work.Patient came home and charged her ins.When she used the pp, she could not make it to work.Pp showed her 'call your doctor' screen, por.Due to type of pp or type of error, troubleshooting could not be done.Later, the rep reported that patient's device was in overdischarge.Further information was provided to rep regarding por and steps to clear por with a clinician programmer.On 2018-may-21, rep further reported that 2 physician mode recharges (pmrs) had been completed and the patient was sent home.Patient charged to 3/4 full over the weekend and was currently depleted.Rep reported that this most recent was patient's 2nd overdischarge.Previous overdischarge was a year and a half ago.At the time of this report, patient was alleging that ins was not holding a charge and had to charge every 10-12 hours.It was reviewed with rep that this was normal after an overdischarge, charging needs to be at least 25% before attempting to interrogate and to tell patient not to turn the stimulation on.Caller reported that he may have the patient recharge every day and meet later to clear the por.No further complications were reported/anticipated.On 2018-jun-12 - additional information was received from the rep.It was reported that por was successful but patient would charge device and it would take a charge and quickly deplete.The issue was not resolved.Patient reported she can't charge device any more. patient's doctor plans on replacing her device.A battery change will be scheduled in next month or so. the patient's weight was unknown as the office would not tell the rep.The provided information was confirmed with the physician/account.

• 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: 7634595
• MDR Text Key: 112208949
• Report Number: 3004209178-2018-14235
• 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
• Report Date: 06/25/2018

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: 12/28/2014
• 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: 06/12/2018
• Initial Date FDA Received: 06/25/2018
• Date Device Manufactured: 02/13/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR