MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem Burning Sensation (2146)

Event Date 02/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The patient reported that they had to charge with staples in because their implantable neurostimulator (ins) battery depleted.The first charge was (b)(6) 2016.The patient saw thermometer screen on and ins site felt hot since first charge session on (b)(6) 2016.It was noted that the ins felt hot during charge.The patient had their ins replaced two weeks ago due to normal battery depletion.Nointerventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Event Description

Additional information was received from the patient stating that the implant itself was getting hot during recharging.The temperature icon was on the recharger and it came on a lot.It took them all day to charge because of it.The patient disconnected and then they tried again in 15 minutes.The issue had not been resolved, they did not know what to do.The patient told their manufacturer representative (rep), and health care professional (hcp).The patient inquired if it having to charge every four days with the new system was normal.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5441298
• MDR Text Key: 38699135
• Report Number: 3007566237-2016-00818
• 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: 03/22/2016

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: 07/14/2016
• 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: 02/12/2016
• Initial Date FDA Received: 02/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2016
• Date Device Manufactured: 08/18/2015
• 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: 00055 YR