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

Model Number 37712

Device Problems Failure To Run On AC/DC (1001); Energy Output Problem (1431); No Device Output (1435); Failure to Power Up (1476); Charging Problem (2892); Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Malaise (2359); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 37743, serial# (b)(4), product type: programmer, patient.

Event Description

The consumer reported that they had been very ill, their back had been very bad, and had been in bed for quite awhile off and on.The patient had been in the hospital twice in an ambulance for their back.It was reported that the patient's stimulator had not been working.They had been "out of it" due to bipolar issues and the patient was in chronic pain.There was report that the patient was not being treated for it.The patient reported that they were having issues with the patient programmer.They were not able to "power it up" and could not turn therapy on or adjust settings.It was reported that the patient was not able to troubleshoot alone and was having high bipolar issues.Recommended the patient to follow up with their healthcare professional (hcp).The patient did report that they would call their hcp but also noted that they do not have a hcp.Relevant medical history includes radiculopathy.

Event Description

Additional information received from the patient reported their previously reported issues had not been resolved.The patient stated that they were two hours away from home and didn¿t have their external device with them at the time of the call.It was reported that the patient was on a ¿bipolar high¿ so they were in a home.The patient mentioned that they were having issues mostly with their back, but also with their shoulder and neck.The patient reported that their neck was tweaking out because they needed to be in a quiet place and they weren¿t.It was also noted that the patient had laryngitis and was unable to get treated.It was unknown when the back, neck, and shoulder issues began.

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

Additional information received from the consumer indicated that the patient was in the hospital for a month because of bipolar issues and once they came back, they tried contacting their implanting physician but was told that they had not been in their office for 5 years and they would not see them anymore.All the information that was stored there was also destroyed.

Manufacturer Narrative

Concomitant medical products: product id 37743, serial# (b)(4), product type programmer, patient product id: (b)(6), serial# unknown, product type recharger.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

Additional information received from the consumer indicated that the patient would look for a new doctor when they received physician listings.The recharger did not power up and did not recharge.The patient unplugged the recharger and then the recharger was on.The patient had not recharged since (b)(6) 2016.

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

Additional information was received from the consumer regarding the patient.It was reported that the patient was still having problems trying to get the device to power up.The patient stated she was going to seek assistance from her new healthcare professional to help resolve the issue.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information received.Patient reported their ins stopped working to provide them with therapeutic relief about 5 or 6 years ago.Pt added they wanted a replacement spinal cord stimulator (scs) and an "epidural." pt noted they were scheduled to meet with a mdt rep and their hcp to discuss replacing the ins.Pt didn't notify a mdt rep about the situation.Pt noted their hcp referred them to another hcp to be their managing hcp.The patient was redirected to their healthcare provider to further address the issue.

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: RESTORE ULTRA
• 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: 6238894
• MDR Text Key: 64422972
• Report Number: 3004209178-2017-00568
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2009
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2023
• Date Device Manufactured: 08/18/2008
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female