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

Model Number 97714

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Use of Device Problem (1670); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)

Patient Problem Seroma (2069)

Event Date 08/12/2016

Event Type  Injury  

Event Description

The patient reported that they were unable to communicate with their battery using their programmer.It was determined that the battery had depleted due to not charging since implant.The manufacturer representative (rep) reviewed how to charge and the patient was able to charge their battery.They reported difficulty maintaining 6-8 charging bars.At the time the rep determined this to be due to patient not having a post-operative charging appointment yet.On "6/19".The patient reported getting 6-8 charging bars but taking over three hours to charge battery.The patient was scheduled for a post-operative appointment on "6/23".It was noted that would determine at that appointment if the issue was due to patient compliance or battery issue.The event was not determined to be reportable until the call on "6/19".The patient was implanted on (b)(6) 2016.On (b)(6) 2016 the patient was seen on the office and demonstrated proper charging techniques and the patient was able to achieve 6-8 couplings bars while charging and hold charge.Other relevant medical history includes spinal pain.Additional information was received from a healthcare professional via a rep.It w as reported that the rep received notice from the physician that the patient was considering a battery change to a primary cell battery.Additional information was reported that they were unable to charge and were very unhappy with their unit.It was reported that this had nothing to do with the health care professional (hcp).The patient was informed "5 minutes" before implant surgery of their option for rechargeable versus primary cell device.The patient opted for the rechargeable unit but said that it was the worst decision that they had made.The patient only used the device about 3 days since they had to avoid charge depletion as they had never been able to charge the ins to full.It was reported that they had only been able to pair to the ins using the implantable neurostimulator recharger (insr) for a minute or two.The ins was reported to be moving around due to a build-up of fluid in the ins pocket.The ins was currently ½ charged.The patient thought that they had 2 choices either a pocket revision or just to replace the ins with a primary cell.The patient stated that they would prefer to have a primary cell device.The patient had an appointment to follow-up with their hcp scheduled for (b)(6) 2016.They were trying to get the date bumped up.The patient was working with the hcp and manufacturer representative regarding the recharging difficulties.The patient spoke with the manufacturer representative in (b)(6) a couple of weeks before (b)(6) 2016 about these issues.Additional information from the manufacturer representative reported that the patient was unable to charge due to range of motion and the battery moving in the pocket.It was attempted to use adhesive discs but it did not work due to the battery moving.The manufacturer representative was going to meet with the patient again on (b)(6) 2016.It was reported that the fluid buildup and inability to charge started in early to middle (b)(6) 2016.

Event Description

It was reported on (b)(6) 2016 that the patient's symptoms started to return about 1 week prior to the report in (b)(6) 2016.Additional information was received from a patient letter on (b)(6) 2016 reporting that their symptoms were since implant.The "implant continuously 'floats' inside [their] body." it was reported that the charger could not stay connected to the implant in order to charge it.The charger only connects for 2-3 minutes at a time and then would restart the locating process again.The patient stated that there were no circumstances that led to their symptoms and indicated by crossing out the words "return of" in regards to their symptoms which clarifies that the symptoms were not a return but had been occurring since implant.The patient stated that they had been calling the manufacturer since the onset and that this was their 3rd call regarding the issue.The patient reported that the symptoms had not resolved and that there were only 2 resolutions to the problem.One was that they could go back into surgery and anchor the same implant so that it did not float or, two, they could go back into surgery and implant a new non-rechargeable implant.Additional information was received from the manufacturer representative on (b)(6) 2016 reporting that the patient was being scheduled for a battery pocket revision the battery was able to move about in the pocket.The patient was not scheduled yet at this time.It was reported that they were able to charge if they sat still for short periods of time.

Event Description

Additional information received from the consumer indicated that the patient had the ins repositioned on (b)(6) 2016.The doctor used a medical pouch and anchored it down and now the ins was secure in the pocket.The device was now doing outstanding.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6028571
• MDR Text Key: 57450446
• Report Number: 3004209178-2016-21756
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/05/2017

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: 02/28/2017
• 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: 09/30/2016
• Initial Date FDA Received: 10/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/14/2016
• Supplement Dates FDA Received: 10/31/2016; 01/05/2017; 09/26/2017
• Date Device Manufactured: 04/07/2016
• 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: 66 YR