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

Model Number 37714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Malaise (2359); No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2014

Event Type  Injury  

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

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that the reason for implant was that ¿during a cardiac pass, the hcp inserted a needle 8 times, damaging 5 nerves.¿ this had caused nerve damage and the patient stood to do their job because it was not comfortable to sit or bent.That was when a coworker referred the patient to the manufacturer.It was reported that the patient had been on morphine for almost 20 years and was trying to wean themselves off of it.The patient also noted that they had stopped taking their fibromyalgia medicine.The patient reviewed that as a result of this they would like to program the implantable neurostimulator (ins) to expand/cover more area.They tried to call a manufacturer representative they knew but did not hear back.The reason for the call was to get an appointment with a manufacturer representative for reprogramming.The patient did not have a health care professional (hcp) but had a particular hcp in mind to have a manufacturer representative meeting requested.This event started 2-3 months ago in 2016.It was reported that the patient had a previous implantable neurostimulator (ins) replaced because it would not charge.The patient clarified that those implants did not have the technology to charge and reached normal battery life.It was reported that the patient¿s following/pre-existing medical conditions were unrelated.These unrelated conditions were fibromyalgia and primary autonomic failure which ¿screwed with¿ the patient¿s blood pressure, pain, etc.The patient reviewed that they had most died while in the hospital around the time of the ins battery replacement.The patient had been admitted to the hospital and was very ill for about a week with their blood pressure at 29.The patient stated that they thought they the patient had been dying.It was clarified that with their illness they also replaced the ins for normal battery life but the patient did not make the decision to have a rechargeable device.The patient did not know if their spouse had made that decision as the patient had just assumed that the technology had changed.It was reported that the issue was taken care of at the time.The patient had recovered and it did not appear to be related to the ins therapy but it was reported to have occurred around the time that the new ins had been placed.This had been around (b)(6).Manufacturer records show that the ins replacement had occurred on (b)(6) 2014.

Manufacturer Narrative

Due to additional information, the event is not a serious injury and the hospitalization is not related.The patient codes (b)(4) no longer apply.

Event Description

Additional information was received from a healthcare provider (hcp) on (b)(6) 2017 reported that the previously reported life threatening event, illness, low blood pressure, and hospitalization were not related to or caused by the ins replacement surgery.It was reported that the patient was in the hospital on (b)(6) 2014 for right hip and groin.At the time their blood pressure was 128/48.

Manufacturer Narrative

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

• Brand Name: RESTORE SENSOR
• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6315365
• MDR Text Key: 66921655
• Report Number: 3004209178-2017-02925
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Date Device Manufactured: 11/19/2013
• 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 Outcome(s): Hospitalization
• Patient Age: 61 YR