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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330)

Event Date 01/30/2017

Event Type  malfunction  

Event Description

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient turns stimulation on at night and over the weekend they woke up with the stimulation off.The patient said that they aren't able to recharge.The patient stated that they were getting the reposition antenna and the poor communication screens on the recharger and patient programmer respectively.The patient reported feeling stimulation changes when they move and walk but not when sitting.The patient last felt stimulation over the weekend.The patient said that they normally charge 2 times per week.The patient reported that their last charging session was more than 1-3 months ago.The patient was referred to their healthcare provider as overdischarge is possible.The patient also reported that the recharger is uncomfortable as the patient is skinny.A manufacturer's representative (rep) was requested at the patient's next appointment.

Event Description

Additional information was received from the manufacturer representative that the doctor's office got the follow up letter.The rep talked to the patient and were able to charge the device without having to do a physician mode recharge (pmr).Rep was going to meet with the patient on (b)(6) 2017 to turn on the therapy.

Manufacturer Narrative

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

Additional information was received from a manufacturer's representative (rep).It was reported that the rep had met with the patient.The rep stated that they walked the patient through proper recharging process.Once the patient received the por message they were able to hit the green button on the recharger and begin to charge.Once device was fully charged the patient met the rep at the providers office to clear por and start stimulation.At this time the issues were resolved.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6293042
• MDR Text Key: 66256500
• Report Number: 3004209178-2017-02270
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup,Followup
• Report Date: 02/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Date Device Manufactured: 12/28/2015
• 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: 53 YR