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

Model Number 37702

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Human-Device Interface Problem (2949)

Patient Problems Neuropathy (1983); Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331); Insufficient Information (4580)

Event Date 09/06/2013

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.It was reported that the battery was just moved on (b)(6) 2020.No further complications were reported.

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who is implanted with a neurostimulator for spinal pain.It was reported that the patient got a replacement in 2013 because the neuropathy in the left foot was getting worse and going to the right foot.The patient had told the physician that she wanted the implantable neurostimulator in the abdomen, not in the butt.However, when the patient woke up, the implant was in her side by her hip bone.The implantable neurostimulator was sticking out and pushing against the skin and was uncomfortable.The patient was told that it was implanted this way because the leads would not go to the abdomen.The patient¿s neuropathy only bothers the patient in the summer/in the hot or at night.The patient only turns the implantable neurostimulator on during these times, but also uses lidocaine patches.The patient cannot leave the stimulator on all night.Additional information was received on 2020-feb-05 reporting that both implantable neurostimulator (ins) batteries were implanted in the wrong location.The health care provider (hcp) had difficulty putting this one in where it belonged.There was a difference in opinion regarding abdomen versus hip.The current ins was sticking out of the patient's hip.It had worked its way up their butt and was now on their side resting and sticking out of their hip bone.It was quite large and causing issues due to it sticking out , it was painful, and when they sat down they could feel the ins grinding against their bone.The patient needed surgery because of the issues noted and was meeting with their hcp to discuss pricing and the ins options.No further complications were reported.

Event Description

Patient repeated information that was already reported.Patient reported they hurt their knee on 01 november 2021 and was going to physical therapy for the past 2.5 months.Pt said physical therapy seemed to be helping and the pt was almost back to 100% when they fell this previous saturday.Pt got an x-ray and a ct scan, but needed an mri because the x-ray and ct scan were not helpful.Pt said they use their therapy for "neuropathy." pt's orthopedic hcp was dr.Pander, but pt did not have an hcp for their spinal cord stimulator.Pt had been in mri mode before and said they knew they were conditionally brain only eligible.The patient was redirected to their healthcare provider to further address the issue.Pt said they did not want to have another surgery.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 9741542
• MDR Text Key: 187647940
• Report Number: 3004209178-2020-03869
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2022
• Date Device Manufactured: 10/12/2012
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 79 KG