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

Model Number 97712

Device Problems Energy Output To Patient Tissue Incorrect (1209); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395)

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

Event Date 04/27/2014

Event Type  Injury  

Event Description

It was reported,the patient¿s stimulation just stopped and she did not feel it anymore.There were no falls, trauma, or activities associated with this event, just normal activity around the house.The issue started in the morning before the patient charged.Later in the afternoon, she charged and her implantable neurostimulator (ins) was currently fully charged.It was noted, the patient typically used stimulation at 0.8 ¿ 1 volts for pain in both legs and after turning it up she still did not feel stimulation.The next day, a manufacturer representative ran impedances at 3.0 c when the patient was sitting and there were no out of range values.With reference electrode of 0 impedances were in the range of 540-634, with reference 1 the range was 613-400.Reference 2 results were as follows: 2-3 was 396, 2-8 was 375, 2-13 was 386, and 2-14 was 399.Reference 3 results with pairs 4, 8, 9, 10, 14, and 15 were in the 300s.Looking at the remaining reference electrodes the range continued to be in the 300-500 range.Group impedance for a1 was 327 ohms and a2 was 295.The manufacturer representative ran impedances with the patient supine at 0.7 v and there were no out of range results, all were in the 500 ohm range with reference 0 except 0-5 was in the 800 range.It was noted, the patient had not noticed any change in recharging.Recharging stats showed the patient had charged multiple times the previous day, for 0.5 hours, 3.3 hours, and 0.6 and she also charged for 0.7 hours on (b)(6).It was reported, the patient had two programs: program 1 with 1+, 2-, 3+ and program 3 with 8+, 9-, 10+ and she mainly used program 1.The patient did not see any errors or messages on her patient programmer (pp).The manufacturer representative tried reprogramming all over the lead and the patient continued to not feel stimulation.When they used electrodes higher up in the middle of the lead the patient felt spasms in her mid-back and between her shoulder blades which they could not attribute to the manufacturer representative turning up stimulation but they tried settings between 8-9 v and at this setting the patient did not feel any stimulation in her legs.It was noted there were no reports of any changes/movement in the position of implanted components.Yesterday, the patient was sitting on the edge of her bed with stimulation on for about an hour.She knew she was going to lie down so she lowered stimulation down to 0.3 v and when they turned it down to 0.0 v she felt stimulation for a short period of time.The manufacturer representative suspected the patient was feeling stimulation from program 2 because when the patient came in today they were set at 0.8 v for program 1 and 0.2 v for program 2.Later that day an x-ray was performed and the patient¿s lead had definitely moved.It was noted, it looked like the lead flipped or fell over on itself.The pain physician did the x-ray today and a neurosurgeon nurse would be in touch with the patient for a consult.Additional information received three days later reported, the patient was scheduled to follow-up with the implanting physician to determine when a revision of the lead would take place but the date was unknown.The cause of the lead moving was unknown.The patient was not receiving any therapy at that time.Additional information received six days later reported, the patient was scheduled to have her lead revised on (b)(6).Additional information has been requested but was not available as of the date of this report; a follow-up report will be sent if information becomes available.

Manufacturer Narrative

Product id 97754, serial# (b)(4); product type recharger product id 97740, serial# (b)(4); product type programmer, patient product id 39565-65, serial# (b)(4), implanted: 2014 (b)(6); product type lead.(b)(4).

Event Description

The company representative confirmed that the lead was revised on (b)(6) and nothing was explanted.The lead was simply repositioned and re-anchored.The patient was doing well and was receiving effective therapy.

• 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: 3815187
• MDR Text Key: 19797925
• Report Number: 3004209178-2014-09099
• 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,Followup
• Report Date: 04/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2014
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2014
• Date Device Manufactured: 10/17/2013
• 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: 00037 YR