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

Model Number 97714

Device Problems Intermittent Continuity (1121); Unexpected Therapeutic Results (1631)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

The patient never experienced therapeutic effect and was scheduled to have the device removed tomorrow because the pain was worse with implant.The trial therapy helped considerably but since permanent implant it has not helped.The patient¿s pain was not constant.The company representatives would try to adjust the stimulation and then the patient¿s pain would go away.The patient would turn the device on and after a brief time the patient would feel impulses around the ins which caused muscles to spasm more than normal.The pulsing sensation would go away when the ins was turned off.The patient felt better with it turned off than on even after turning it down to low frequency.Everything that was tried caused the patient to end up with more pain.The trial period was short and a few more days would have given the patient a better feel for it.The patient later reported on (b)(6) 2014 that the device was removed on (b)(6) 2014.The device never helped their condition and only made it worse, very painful.Additional information has been requested.

Manufacturer Narrative

Concomitant products: product id 977a160, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type lead; product id 977a160, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type lead; product id 97740, serial# (b)(4), product type programmer, patient; product id 97754, serial# (b)(4), product type recharger.(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: 3619787
• MDR Text Key: 18855289
• Report Number: 3004209178-2014-02676
• 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
• Report Date: 01/20/2014

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: 08/14/2014
• 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: 01/20/2014
• Initial Date FDA Received: 02/10/2014
• Date Device Manufactured: 09/19/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00082 YR