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

Model Number 97714

Device Problems Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892)

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

Event Date 12/09/2015

Event Type  malfunction  

Event Description

The patient via manufacturing representative reported that they are charging their device too often.They further explained that they are charging as much as 2 times a day, and that their implantable neurostimulator (ins) is not holding a charge.They stated that their ins battery depleted by 50% with stimulation off.It was reported that the patient had been charging for short durations, and generally not getting past 50% full.The manufacturing representative's data didn't show that the patient was charging as often as they claimed.It was noted that coupling could be an issue for the patient.The patient also mentioned that they get a pain down their leg.They stated that the pain feels like a sharp burning sensation and can occur periodically or consistently during recharging sessions.It was noted that these sensations only occur when the patient is recharging, and that they recharge with their stimulation off.At the time of the report, the patient was getting 6 coupling bars.When the patient recharges, they lean back against a chair so they can better press the antenna into the ins pocket area for better coupling.The patient stated they have never had an electrical sensation prior to being implanted.It was noted that the patient's recharging issues and burning pain have occurred since (b)(6) 2015.It was recommended that the patient should try charging their ins to 100% to increase time between charging sessions.The patient also sees the thermometer icon every time they recharge.The manufacturing representative stated that it didn't seem the icon was being displayed inappropriately.They noted that they stop charging when they see the thermometer icon.The patient was going to follow up with the manufacturing representative to further review recharging practices.The patient was implanted for spinal 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

Follow up information was received from a representative (rep).The rep stated that the patient was no longer seeing the thermometer alert and was no longer having pain down his leg.The rep reported that he was leaning up against something when charging the device.The patient was instructed on charging and his issues resolve.The patient stated that he was not using his stimulator all the time as he previously did.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6077346
• MDR Text Key: 59189860
• Report Number: 3004209178-2016-23193
• 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
• Report Date: 12/09/2016

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: 10/14/2016
• 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: 10/10/2016
• Initial Date FDA Received: 11/03/2016
• Supplement Dates Manufacturer Received: Not provided; 11/17/2016
• Supplement Dates FDA Received: 12/09/2016; 09/27/2017
• Date Device Manufactured: 11/17/2015
• 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: 51 YR