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

Model Number 97712

Device Problems Intermittent Continuity (1121); Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Cramp(s) (2193); Discomfort (2330); Injury (2348)

Event Date 07/11/2014

Event Type  Injury  

Event Description

Additional information received reported that in addition to incontinence, the patient had not had relief of frequency since implant.The patient had seen the representative two weeks after implant for programming changes and ¿one other time¿ to change the program.It was noted the patient had a urinary tract infection which could have been contributing to their symptoms.No intervention was noted and no outcome was provided with this event.Further follow up is being conducted to obtain this information.An additional follow up report will be sent if additional information is received.

Event Description

It was reported that during the trial the patient had some improvement and they felt it was enough to go forward with the permanent implant.Since implant, the patient had an overstimulation sensation and stimulation kept revving up on its own at different times and was very uncomfortable.Stimulation seemed to be changing, sometimes after the patient showered, sat in a car, or lay down.The patient¿s toes were ¿cramping up like charlie horses¿ and she had not obtained the desired therapy benefit.Especially at night, there were five or six times in a row where the patient was losing control of the bladder.The patient wasn¿t able to get in for a follow-up appointment until the week following the report.It was later reported that the patient had a rechargeable device and was getting spontaneous increases in stimulation, it was causing pain, and she was still having incontinence.Her doctor¿s office said this was not normal and they weren¿t sure what was happening.The patient was worried and concerned the implant was defective.The next day, it was reported that the patient had an appointment with a physician¿s assistant the past week and the physician¿s assistant was unable to communicate with the implantable neurostimulator (ins) to change a program after several attempts.The clinic was to get back to the patient but she hadn¿t heard anything.The patient had pain in the lower back near the sacral nerve and was concerned that maybe the implant had moved.She though the device should be removed and checked if the ins may be malfunctioning and was concerned about any injury that may occur or has occurred.The patient¿s lower back was hot and burning.Additional information has been requested but was not available as of the date of this report.

Manufacturer Narrative

Device used for off label indication.The indication the device was used for was ezw.Concomitant medical products: product id 3889-28, lot# va0j956, implanted: (b)(6) 2014, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the manufacturers representative (rep) reported that the patient was trying to charge her implantable neurostimulator (ins) but it did not go past 25%.The patient tried charging it for 1-1.5 hours and it remained flashing at 25%.The patient noted that she got all 8 coupling bars.

• 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: 4020002
• MDR Text Key: 4719173
• Report Number: 3004209178-2014-15501
• 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,con
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Date Device Manufactured: 06/11/2014
• 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: 00065 YR