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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 09/03/2014

Event Type  malfunction  

Event Description

It was reported that since implant the patient had had 5 occurrences where stimulation shut off for a very short period of time and came back on within a second or so.The patient had not checked the stimulator with her programmer when this occurred.It did not seem related to movement.Stimulation was otherwise fine, except for the loss of stimulation sensation.The patient was sensitive to it turning off as she felt a ¿let down¿ and it felt like a sudden change.Adaptivestim was not being used at this time.The patient met with a company representative on (b)(6) 2014.The issue had not happened again.Adaptivestim was activated and she was also given a new program to help with pain on the right side.The patient was doing very well.Impedances were all within normal limits.It was reviewed that it may have had something to do with the leads not being scarred in.No additional information was provided and follow up attempts were considered complete.

Manufacturer Narrative

Concomitant 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 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: 4167612
• MDR Text Key: 4867959
• Report Number: 3004209178-2014-19588
• 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: 09/22/2014

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: 06/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/13/2014
• Date Device Manufactured: 07/17/2014
• 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