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

Model Number 97714

Device Problems Failure to Interrogate (1332); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Tingling (2171)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

A healthcare professional (hcp) of a clinical study reported the patient did not experience stimulation when standing as reported on 21-oct-2015 to the study; paresthesia was experienced only while sitting.On (b)(6) 2015, the patient had a clinic appointment and reported unsatisfactory coverage of stimulation; the patient was unable to achieve stimulation in standing position or left leg and painful thoracic stimulation was experienced.During the clinic appointment, the device was reprogrammed which resolved the thoracic stimulation but paresthesia was still only felt in sitting position.On (b)(6) 2016 appointment, stimulation was felt only when lying on side.The battery was found to be depleted so the hcp was unable to interrogate the device.On (b)(6) 2016, after recharging the device, there was only left side stimulation.An x-ray was taken which determined the lead migrated/dislodged.A lead revision was performed on (b)(6) 2016 and the event required in-patient or prolonged hospitalization.Reprogramming was attempted at a clinic review post revision on (b)(6) 2016 but unable to get satisfactory stimulation.The manufacturing representative attended a clinic visit on (b)(6) 2016 for reprogramming of high density settings.It was noted the device was turned off 11 days after revision due to unsatisfactory stimulation.An x-ray was taken on (b)(6) 2016 showing position of lead checked at second revision showed lead migration on immediate post-operative images; lead had coiled in epidural space.On (b)(6) 2016, the lead was repositioned.The device was interrogated and reprogrammed on (b)(6) 2016.The event was ongoing and related to device or therapy but not implant procedure.

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 received from the healthcare professional (hcp) of a clinical study reported that the outcome was resolved without sequelae.Interventions included a clinician reset of battery and the patient was told to go home and charge the battery for the next 2 days on (b)(6) 2016.Interventions included wound review on (b)(6) 2016.Interventions included reprogramming on (b)(6) 2016.Device interrogation/device data showed that the battery needed clinician reset and full charging.The device was interrogated and the doctor and manufacturing representative had programmed the patient¿s device and the patient had full coverage of their leg.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6213781
• MDR Text Key: 63563381
• Report Number: 3004209178-2016-27433
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Date Device Manufactured: 01/15/2014
• 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 Outcome(s): Hospitalization; Required Intervention