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

Model Number 97712

Device Problems Failure to Interrogate (1332); Overheating of Device (1437); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problems Nausea (1970); Pain (1994); Burning Sensation (2146)

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical devices: product id: 37092, product type: accessory.(b)(4).

Event Description

A consumer reported a persistent thermometer icon.When she would go to charge, the consumer got the temperature gauge screen and her implantable neurostimulator (ins) would feel really hot, but was still able to charge.The consumer noted she was told by a manufacturer representative that the device should not be getting hot while charging.She got really sick in (b)(6) 2015 and could not use her ins because it made her puke.The consumer started using the ins again by the end of (b)(6) 2015 and was having issues keeping it charged.When charging, she had to press against something to charge.The consumer noted the health care professional and representative said she was thin and should not have to push against something to charge.A replacement antenna was requested.Follow-up was being conducted to determine cause, steps taken, and resolution of the reported event.If received, this event will be updated.Indication for use included non-malignant pain.

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 the patient.The patient reported that they couldn't charge or connect to their ins in (b)(6) 2017.The patient reported a reposition antenna screen on the ins recharger.They encountered a poor communication screen on the patient programmer.The patient reported that they had been able to turn off their stimulation a week prior to the event and that they were nauseous and felt sick, but this was determined to be unrelated to the device or therapy.The patient reported that their device was not working as well as it had originally and specified that it was working well for their small fiber neuropathy pain, but may not be working for their crps pain in their leg.The patient noted that their pain was spreading.The patient was seeking a new managing healthcare provider and called their manufacturer representative but did not get a response.No further complications are anticipated.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5428811
• MDR Text Key: 38467179
• Report Number: 3004209178-2016-02610
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

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: 06/14/2016
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2017
• Date Device Manufactured: 07/15/2015
• 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: 00036 YR