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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

Date inaccurate, only the month and year are valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the last time the patient saw their doctor, a manufacturer's representative used a device and did something to their system.The representative increased their stimulation too much and stated they decreased it as low as it would go but it still gave them extreme pain.The patient programmer showed the stimulation was on and they were at 0.3 volts.They decreased the stimulation to 0.0 volts but noted they were still feeling pain.The patient was advised to turn their stimulator off and follow up with their healthcare provider.No further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the circumstances that led to the pain even after tuning the stimulation to 0.0 volts was that awful weather was on the way.Patient went to the health care professional (hcp) and the stimulator had too many volts.The voltage was reduced and it was much better.Patient sated " however, today is a beautiful and the stimulator is being bad".Patient sated they will keep trying to get it right.Patient was now at 1:70 volts, seemed ok.Patient said the pain has resolved.No patient symptoms or complications were reported in 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: 7309373
• MDR Text Key: 101372530
• Report Number: 3004209178-2018-04306
• Device Sequence Number: 1
• Product Code: LGW
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

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: 02/14/2018
• 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: 02/25/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 03/19/2018
• Supplement Dates FDA Received: 04/12/2018
• Date Device Manufactured: 03/27/2017
• 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: 73 YR
• Patient Weight: 73