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

Model Number 97714

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: product id: 97754, serial# (b)(4), product type: recharger.Product id: 977a160, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 977a160, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

It was reported that the patient was experiencing stimulation in the wrong location.The device was implanted for the patient's back and legs; the patient felt stimulation in her legs but did not feel much stimulation in her back since implant.When stimulation was increased, stimulation was felt by the ribs area.Stimulation in the ribs was also felt when the patient was on the table at the hospital.It was noted that the patient did not feel stimulation in the ribs at the time of report because she had lowered stimulation.No outcome or interventions were reported for this event.Further follow up is being conducted to obtain this information.If additional information becomes available, a follow up report will be sent.Information about recharging frequently, ins depleted captured in related pe: (b)(4).

Event Description

Additional information received reported that the device was reprogrammed in order to address the stimulation in her ribs issue.The device was reset and it was giving the patient 3 different options.As a result of the reprogramming, the stimulation was moved from the patient's ribs to her side.The healthcare provider (hcp) wants to see the patient again a month later to try to get stimulation in her back.The issue was not completely resolved and the hcp suspects that an additional lead may need to be implanted.

• 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: 4953562
• MDR Text Key: 24651238
• Report Number: 3004209178-2015-14303
• 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
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Date Device Manufactured: 04/21/2015
• 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: 00055 YR