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

Model Number 97712

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 12/16/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional via manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain and complex regional pain syndrome type i.It was reported that patient had a 006 code on the programmer.Patient also reported that they felt sensation of stimulation on sometimes, when the device was noted to be off and on the clinician programmer.Clinician programmer showed stimulation was turned on at 2300 hours.The ins was interrogated, impedances were fine and within normal limit.Recharger history was good.Removing and/or replacing patient programmer batteries did not resolve the 006 code.No further complications were reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from consumer and manufacturer representative.Patient reported the programmer read that stimulator was turned off but patient could feel stimulation.Patient noted they felt stimulation in their left arm.It was reported that from the manufacturer representative that it appeared that the ins was on and programmer was unable to turn it off.Patient guessed the issue was resolved because patient could not turn the stimulator on due to the issue with programmer.Patient reported they thought the stimulator was on but "when she turned it, it increased".Patient stated they have 2 leads, one in "cervical, the cervical is off course positional" and "one in her thoracic".Patient stated since receiving the new replacement programmer, patient saw a message on the programmer with just a circle in the middle of the screen and two arrows on the outside of the circle.Patient reported there was no hand on the screen.It was unable to identify the screen patient was describing and patient reported they were seeing poor communication at the time of the report.When patient unplug antenna and placed programmer directly over ins, on skin, the poor communication was resolved.The programmer antenna was damaged.A replacement programmer antenna was sent.No further complications were reported as a result of this event.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 7129051
• MDR Text Key: 95379888
• Report Number: 3004209178-2017-26251
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

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: 12/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/02/2018
• Date Device Manufactured: 01/19/2015
• 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: 48 YR
• Patient Weight: 84