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

Model Number 37714

Device Problems Use of Device Problem (1670); Delayed Charge Time (2586); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: non-healthcare professional.Information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for non-malignant pain.The patient called their manufacture representative (rep) on (b)(6) 2018 because they are having a hard time recharging the ins.The rep suggested calling patient services for adhesive discs to assist with recharging the ins.They are having a hard time charging the ins as it is taking a length of time that might be too much.The event date was stated as the last couple of weeks, this weekend, and maybe last friday afternoon.Patient services sent adhesive discs to that patient.It was noted that the ins was implanted for their motor cortex in the patient¿s brain.There were no patient symptoms reported and no complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.They reported that the reason why recharging was taking a long time was because the charger was not maintaining consistent contact with the ins while in the recharging holster.The use of adhesive discs resolved this issue.The patient called in requesting a re-order of the adhesive discs.No symptoms were reported.No further complications were reported or anticipated.

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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7715517
• MDR Text Key: 115079194
• Report Number: 3004209178-2018-16515
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2017
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 02/24/2016
• 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 Age: 61 YR
• Patient Weight: 98