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

Model Number 97714

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Response, Decreased (2271); Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that the patient was unable to adjust stimulation.She had been trying for an hour to connect the patient programmer (pp) to the implantable neurostimulator (ins) and saw the sync ins screen and an hour glass screen.Being unable to adjust had happened on and off since implant and the manufacturer¿s representative (rep) had also had some difficulty connecting but was also able to connect.Functionality of regarding how to attach and detach antenna, placement of the antenna over the ins, and synching were reviewed with the patient as well as the possibility of swelling effecting connecting in the first weeks after implant.The patient was able to successfully synch with and without the antenna and turn stimulation on and off.It was noted stimulation was too high when turned on at 4.20 volts.The patient was able to decrease stimulation while therapy was off.Difficulty connecting happened previously around (b)(6) during a shocking event but ultimately the patient had been able to turn stimulation off.A shocking/jolting sensation was reported.The patient¿s leg began to hurt (reason for implant) so the patient turned therapy back on and it ¿just turned on.¿ it was noted the patient had a hot flash from the troubleshooting during the call.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Event Description

The patient¿s health care provider (hcp) confirmed that the cause of the event was determined and was device related.Reprogramming was not needed.The antenna to the remote was not working.Patient reported experiencing overstimulation around (b)(6) 2014.The troubleshooting performed was the patient removed the antenna and only used the remote to adjust stimulation.The patient recovered without permanent impairment.The patient also confirmed that they received assistance and their concerns were resolved.

Manufacturer Narrative

Concomitant medical products: product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 3550-29, lot# n492972, implanted: (b)(6) 2014, product type: accessory.(b)(4).

Manufacturer Narrative

(b)(4).

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4359389
• MDR Text Key: 5119316
• Report Number: 3004209178-2014-24468
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

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: 07/28/2015
• 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: 01/02/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/21/2015
• Date Device Manufactured: 08/28/2014
• 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 Age: 00044 YR