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

Model Number 37712

Device Problem Charging Problem (2892)

Patient Problems Nerve Damage (1979); Paralysis (1997); Therapeutic Effects, Unexpected (2099)

Event Date 11/03/2011

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient reported that they stopped using their device a long time ago because it never gave them therapeutic benefit and it was difficult to recharge.The patient stated that they are having the device removed.No further complications were reported.The patient was implanted for spinal pain, non-malignant pain, and failed back surgery syndrome.

Manufacturer Narrative

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

Event Description

Information was received from a manufacturing representative regarding the patient.It was reported that the patient had their device removed on the day of the report.No further complications were reported.

Manufacturer Narrative

Product id: 3778-60, (b)(4), implanted: (b)(6)2011, explanted: (b)(6)2017, product type: lead, product id: 3778-60, (b)(4), implanted: (b)(6)2011, explanted: (b)(6)2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the health care provider (hcp) and consumer on 2018-mar-15 reporting that after the lead explant the patient had some paralysis due to cauda equina syndrome following the syndrome.

Manufacturer Narrative

Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

Event Description

2017-11-29 crts (b)(4) (con): information regarding pump device omitted as in sr 602225899.The patient reported that they stopped using their device a long time ago because it never gave them therapeutic benefit and it was difficult to recharge.The patient stated that they are having the device removed.No further complications were reported.The patient was implanted for spinal pain, non-malignant pain, and failed back surgery syndrome.2017-12-07 crts 3644622 (rep): information regarding catheter omitted, as included in pe (b)(4).Information was received from a manufacturing representative regarding the patient.It was reported that the patient had their device removed on the day of the report.No further complications were reported.2018-03-15 crts (b)(4) /update (x2) (hcp, con): information regarding the pump was included in pe 702240702.Additional information was received from the health care provider (hcp) and consumer on (b)(6) 2018 reporting that after the lead explant the patient had some paralysis due to cauda equina syndrome following the syndrome.2018-04-11 lfc (hcp): no new information.

• Brand Name: RESTORE ULTRA
• 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
• MDR Report Key: 7074975
• MDR Text Key: 93466561
• Report Number: 3004209178-2017-24689
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2012
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR