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

Model Number 37714

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

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 failed back surgery syndrome and non-malignant pain.It was reported that every time that the patient bends over, ¿it shuts off¿ on her.This was confirmed to mean that the implantable neurostimulator is not turning off, but if she bends over or slouches, the patient no longer feels stimulation.She has never experienced this before and states that she knows something is not right.She uses the patient programmer to adjust therapy if she experiences this, but if she puts the intensity up, when she lies down it¿s too strong and she turns stimulation down.The patient had a fall about a year prior to the report but did not feel that it was related because what she has been experiencing with the stimulation started suddenly about 2 months prior to the report.The patient was redirected to her health care provider to have her internal equipment assessed.There were no further 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 on (b)(6) 2018.It was reported that to resolve the loss of stim with positional movements issue, the patient was to have an appointment for their implantable neurostimulator (ins) to be checked and reprogrammed.There were no further complications 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: 7639117
• MDR Text Key: 112470972
• Report Number: 3004209178-2018-14386
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 06/26/2018
• Supplement Dates Manufacturer Received: 07/06/2018; 08/08/2018
• Supplement Dates FDA Received: 07/18/2018; 10/04/2018
• Date Device Manufactured: 11/05/2014
• 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: 52 YR