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

Model Number 97714

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Event Description

It was reported the patient experienced a loss of therapeutic effect.It was stated the patient¿s stimulation had not been working right for a ¿good while¿ or a couple of months.The patient was redirected to their healthcare provider (hcp).Additional information stated the patient ¿did not understand how her device worked with adaptive stim (as) on.¿ it was noted the patient¿s as feature was turned off and ¿she was good to go¿ at that time.It was reported the patient left her reprogramming session ¿with better pain coverage and was able to feel the stimulation better and more consistently.¿ the patient reported a couple months later that she had an issue with the patient programmer (pp) a few months ago.It was stated ¿i could turn it down but i couldn¿t get it to stay up, you know what i¿m saying, it would go up but if i moved the numbers would go back down, the sensation and i had talked to him about that¿.The patient further clarified that ¿when i turn it up, turn it up to make it stronger, if i moved, i mean i¿d sit there for 5 minutes, if i changed my position of my body the sensation would go down and all the numbers would go down on the remote, you could tell that it was going down¿.If the patient had it on 8 and she got up and walked around it would go down to 5 or whatever the last time she had used on the pp.The patient no longer has the adaptivestim set on the pp.The patient was told not to use the adaptive stim when she was reprogrammed last so she has not been.It was confirmed that the issue was resolved when the adaptive stim was taken off and the patient was on program b.

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 3550-29, lot# n298169, implanted: (b)(6) 2014, product type: accessory; 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 MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4073072
• MDR Text Key: 4740426
• Report Number: 3004209178-2014-16627
• 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: 08/13/2014

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: 10/14/2014
• 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: 08/13/2014
• Initial Date FDA Received: 09/09/2014
• Date Device Manufactured: 11/27/2013
• 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: 00049 YR