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

Model Number 97712

Device Problems Failure to Deliver Energy (1211); Communication or Transmission Problem (2896); Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 05/30/2014

Event Type  Injury  

Event Description

It was reported that the patient had stimulation in the wrong location.Less than 50% therapy relief was noted.The patient no longer felt stimulation in the appropriate areas one day after implant.The patient was seen several days later for reprogramming and impedance testing.Stimulation was not obtained for the ulnar side of her hand where her chronic pain was.Xrays were ordered.A revision was to be scheduled.It was noted that the programmer training was ineffective because the patient was under the effects of anesthesia.The patient was not awake.Instructions were given on how to use the recharging equipment on (b)(6) 2014.It was further stated later on (b)(6) 2014 that the patient did not/never had therapeutic effect.The implant was meant to help the burning and hurt in the patients shoulder and wrist.The patient had been in a lot of pain.She felt a ¿little¿ therapy when she stood in a certain way.The reporter inquired as to why the burning and hurt had not stopped yet.The patient had done a trial which had helped tremendously.Basic functionality of recharger and programmer was again reviewed.A later report on (b)(6) 2014 indicated that the patient had no stimulation sensation.Since implant, when the patient lay down or sat up she didn¿t feel stimulation unless she turned to the right.The patient stated her pain area constantly burned/stings and the stimulation was not cutting it.The patient was advised that programming may be necessary to find same relief as trial.Recharging was again reviewed.A coupling problem was reported.Two coupling bars were seen.The antenna dial was adjusted and there was no coupling with this.The patient was informed that the pocket wound could affect recharge telemetry.The bandage had been removed and there was swelling.The patient was advised to wait a couple of days for swelling to go down and try again.Programmer function was reviewed again as well.The device was synced.Stimulation was on but it wasn¿t doing anything.Adaptive stim was not on.The stimulator battery was charged 75-100%.It was further stated that xrays had been done and a revision had occurred.It was believed that the patient was receiving effective therapy as of (b)(6) 2014.

Manufacturer Narrative

Product id: 977a275, serial# (b)(4), implanted: (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.Product id: 3550-29, lot# n383434, implanted: (b)(6) 2014, product type: accessory.Product id: 97740, serial#(b)(4), product type: programmer.

• 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: 3891638
• MDR Text Key: 4425943
• Report Number: 3004209178-2014-11965
• 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: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/02/2014
• Date Device Manufactured: 01/15/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 00049 YR