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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that the patient felt stimulation starting and stopping (stuttering) when using their adaptive stimulation programs.This occurred when the patient was standing or sitting perfectly still.The patient stated that it was unrelated to the 'stopping/starting' that he feels as the adaptive stimulation adjusts when he changed positions.It had not affected his therapy.The patient was concerned that it may indicate an issue with the stimulator and he worried it may suddenly stop on him.The company representative who saw the patient asked him to try the same programs without the adaptive stimulation on to see if this is replicated.Impedances were run and all came back within normal limits.Reprogramming was also done.The patient¿s status was alive with no injury.Additional information regarding further troubleshooting and outcome was requested.If received a follow up report will be sent.

Manufacturer Narrative

Concomitant products: product id 97740, serial # (b)(4), product type programmer, patient; product id 97754, serial # (b)(4), product type recharger; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(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: 4376007
• MDR Text Key: 5284259
• Report Number: 3004209178-2014-24752
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/10/2014
• Date Device Manufactured: 06/05/2014
• 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: 00058 YR