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

Model Number 97702

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Cramp(s) (2193)

Event Type  malfunction  

Event Description

It was reported that a patient had stimulation in the wrong location.It was stated that the stimulation was ¿in her butt not her back¿.It was stated that the patient¿s device was not working right.It was stated that if the patient wanted to turn her legs off due to cramps she could not.It was stated that when she turned her legs down the stimulation was being turned down in her back.It was noted that stimulation was stronger on the left hand side and not the right side.The patient noted that she would like an x-ray.

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

(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: 3756932
• MDR Text Key: 4468033
• Report Number: 3004209178-2014-07429
• 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: 03/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2014
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• Date Device Manufactured: 06/06/2013
• 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: 00050 YR