MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Pain (1994); Complaint, Ill-Defined (2331); Skin Inflammation (2443); Electric Shock (2554); Weight Changes (2607)

Event Date 03/20/2017

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 3777-60, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.Product id: 3777-60, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.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

Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of lumbar radiculopathy and spinal pain.It was reported that the patient had a back ache and shocking.The patient began the call saying that they thought it slipped out of place, as their back ached all over the back and was shocking them.The patient programmer showed that the stimulation was off.The patient turned stimulation on and didn't resolved the issue.The patient did begin to feel stimulation, but would like the stimulation higher.The patient was able to increase stimulation and was resolved.Patient services was not able to confirm if the patient had more than 1 group, but the patient found that they had more than one.The patient initially stated that they had more feeling the stimulation in the left leg more than the right, when stimulation was increased it felt the same on both legs.The patient was informed how to increase their stimulation.The patient stated that they had a fall, but it wasn't related to this issue.The patient stated that they lost weight over the last 3 months or so, and the weight loss could have led to the lead moving.No further complications were reported or anticipated.

Manufacturer Narrative

Please note that this date is not exact, but an estimate based on reported information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from a patient on 2017-jul-20.The patient stated that beginning 3-4 months ago their battery came out of the pocket and has moved about an inch.It moves around and the corners stick out.It is very obvious and there are calluses on the corners.The patient stated that the pack came out of the holder and slipped a ways down; about an inch.It is pulling on their lead line that goes to their spine so the patient is getting shocks and it is so out of whack because when they turn it on the stimulation goes in their chest instead of their legs, butt, and hips.It must be turned around.The patient is taking it up to try and keep from getting shocked.The patient went to their primary care physician who x-rayed the leads but not the battery and noted that they do not know anything about the device.The patient called their implanting physician but needs a referral for insurance reasons.They were sent a list of physicians to possibly contact.The patient noted that the shocks have been happening for a couple of months off and on and the implantable neurostimulator (ins) gradually slipping occurred probably a month ago.No further complications were reported/are anticipated.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6686269
• MDR Text Key: 79065928
• Report Number: 3004209178-2017-14217
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: 00613994842312
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2017
• Date Device Manufactured: 08/28/2013
• 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 Age: 83 YR
• Patient Weight: 59