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

Model Number 97714

Device Problems No Device Output (1435); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Device Overstimulation of Tissue (1991); No Known Impact Or Consequence To Patient (2692)

Event Date 05/08/2017

Event Type  malfunction  

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

Information was received via a manufacturer representative from a consumer regarding a patient who was implanted with a neurostimulator.It was reported that there was a power on reset after returning home from traveling on a commercial airline.The patient could not get her stimulator to work.They tried using the patient programmer to turn the device back on with no luck.The patient also tried replacing and checking the batteries in the patient programmer to no avail.The manufacturer representative was meeting with the patient the week of (b)(6) 2017 to interrogate the device.The issue was not resolved, and no surgical intervention was planned or performed at the time of the report.There were no patient symptoms or complications reported.

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 representative.It was reported that the patient had felt a "surge" of stimulation that lasted for one minute while the patient was on the airplane.The patient reported that they felt tenderness at the ins site once the "surge" subsided.It was reported that there seems to have been some electromagnetic interference (emi) while on the airplane.Interrogation was performed and impedances were checked and it was determined that the system was functioning normally.The por was reset and the issue was resolved.No further complications are anticipated.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6566719
• MDR Text Key: 75214877
• Report Number: 3004209178-2017-10271
• Device Sequence Number: 1
• Product Code: GZB
• 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,Followup,Followup,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• Date Device Manufactured: 02/19/2015
• 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: 78 YR