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

Model Number 97702

Device Problems Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Unintended Collision (1429); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Nerve Damage (1979); Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

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

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer implanted for post-lumbar laminectomy syndrome and spinal pain reported they fell down a flight of stairs, and didn't know if they dislodged the implant or what was happening. The consumer was in a lot of pain and the implantable neurostimulator (ins) wasn't doing anything. On (b)(6) 2016 the consumer was able to get the ins to turn on but "couldn't get it do anything," they couldn't feel stimulation, and it was hard to turn off. It was further reported the intensity was unable to be changed and the ins felt different, and they had a feeling it was dislodged. It was noted the consumer had a facet joint injection and was afraid to turn their stimulator on after falling, and wanted to let everything settle. An appointment was scheduled with the healthcare provider (hcp) for (b)(6) 2016, and they wanted a manufacturer's representative (rep) to be there. The consumer was able to meet with a rep. Who was easily able to active their stimulation by simply increasing their amplitude. An impedance check was performed with all results within normal limits. Stimulation was able to cover the consumer's back and legs which was the coverage area they had prior to the report fall, however, they no longer needed stimulation in their legs, and only wanted it in their back. Reprogramming was attempted but the rep. Was unable to cover their back pain without stimulation in the thighs. During the meeting the consumer stated she had been told the continued long term use of stimulation caused nerve damage and increased pain, so they blamed their increased pain on stimulation. As a result they decided not to use it. The rep. Let the physician know of the consumer's concerns and was told the consumer may be having some emotional issues. The rep. Met with the consumer again on (b)(6) 2016 and gave them a new program to try. The physician spoke with the consumer and explained the difficulty of covering all of the back pain without getting stimulation to their legs. The physician also gave the consumer a back brace since they suspected that some of their pain was due to compression fractures.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 5837229
• MDR Text Key: 102022377
• Report Number: 3004209178-2016-15288
• Device Sequence Number: 1
• Product Code: LGW
• 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

• Type of Report: Initial,Followup
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/28/2015
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/11/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/01/2016 Patient Sequence Number: 1