MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESTORESENSOR MRI; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Unintended Collision (1429); Appropriate Term/Code Not Available (3191)

Patient Problems Fall (1848); Pain (1994); Therapeutic Response, Decreased (2271); Malaise (2359)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The chronic pain patient reported through a manufacturer representative that they experienced a stimulation issue following a fall.It was noted the patient¿s device was implanted under the skin of the patient¿s buttock and that the patient had fallen down and seemed to fall on his hips.After the fall, the patient did not feel well and although stimulation was delivered, the patient did not have a feeling of stimulation within several minutes.The patient checked the status of their stimulation with their controller and the controller indicated the stimulation was on.The patient then turned their stimulation off and turned it back on and while the patient had a feeling of stimulation at first, the feeling disappeared.Telemetry and impedance testing was performed using the physician programmer and found no abnormalities, though it was noted the patient did not have a feeling of stimulation.It was noted that ¿the device was hit due to the patient falling down¿ and that this may had led or contributed to the reported issues.The implantable neurostimulator (ins) was replaced on (b)(6) 2018 as the patient had experienced a recurrence of pain due to their loss of stimulation and requested the device replacement.It was noted that pre-operative impedance testing was performed and again confirmed there was no particular issue.Impedance testing was performed during the replacement procedure with the new ins and also confirmed there was no particular issue.Stimulation was started with the replacement ins and it was noted the patient could feel stimulation.It was confirmed that stimulation could be felt well still after the patient returned to the general ward.It was noted that ultimately the cause of the stimulation disappearing was unknown.No further complications were reported or anticipated.

Manufacturer Narrative

The manufacturing site id captured has changed from (b)(4) at this time, but cannot be updated due to constraints with the regulatory reporting system.Additional information received also indicated the notified date for the initial regulatory report filed on 2018-jul-20 should have been 2018-jun-26 instead of 2018-jun-27, as reported at that time.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information reported the patient fell one meter and hit his bottom, where the ins was implanted.The patient¿s stimulation turned on and off intermittently.No further complications were reported or anticipated.

Manufacturer Narrative

(b)(4).Device evaluation: analysis of the implantable neurostimulator (ins) found the ins was functionally okay with insignificant anomalies.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.

Manufacturer Narrative

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

• Brand Name: RESTORESENSOR MRI
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7708535
• MDR Text Key: 114670595
• Report Number: 3007566237-2018-02178
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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