MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97712

Device Problems Vibration (1674); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Nausea (1970); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Effects, Unexpected (2099); Distress (2329); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 10/10/2013

Event Type  Injury  

Manufacturer Narrative

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

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 patient who was implanted with a neurostimulator for non-malignant pain. It was reported that the patient was frantic during a call and the situation was serious, leading patient services to initiate immediate troubleshooting. It was reported that on (b)(6) 2016 the patient started experiencing overstimulation. The device was vibrating like crazy and causing the patient pain. The patient stated that they were at the health care professional (hcp) office and had it set to 3. 00v because they were in a lot of back pain. They tried to decrease the stimulation but it was not turning down. The patient was pressing the second button on the side of the programmer (the ins off button). The patient tried to use the charger to turn the ins off but stated that it just beeped and did not turn off. It was reported that the patient was bent forward because the charge was so strong. Stimulation was causing nausea. The stimulator had caused the patient problems since implant. The patient then said that the problems had not been since implant. Since implant the patient got stabbing pain when the device was too high. It was reported that programming was never right. The patient reported that they did not feel right and their mouth was dry. Stimulation felt like it was at 800 or 900. There had been no falls or traumas. The patient confirmed that they did not have a charge in the office but then confirmed that their battery had not gone into discharge and had plenty of charge. Patient services advised that a physician mode recharge (pmr) be performed. After the count-down the patient reported that they did not feel relief or a reduction in stimulation. During the call, the patient was able to turn stimulation off using the programmer and confirmed that the lightning bolt was gone. They had gone to the podiatrist the day before but reported that they did not have any emi exposure. An information screen was seen on the programmer. The patient reported that the patient programmer increased from 1. 4v to 1. 8 v without pressing any of the buttons on the patient programmer. The patient confirmed that the buttons on the programmer were not stuck. During the call, the patient pressed each button one time firmly to troubleshoot. After this, the patient reported that they thought one button did not look right and was pushed down a little. The patient then stated that maybe they were seeing things regarding the button. It was reported that the stimulator was going to be taken out for a pain pump to be put in. The patient then hung up as they were receiving a call from their manufacturer representative. Before the call ended, the patient was redirected to seek urgent help from an hcp if they deemed it necessary.

Event Description

Additional information was received from a manufacturer representative reporting that they saw the patient on (b)(6) 2016. All system impedances were normal. All functions with the patient programmer, antenna, and implantable neurostimulator (ins) were normal. The programmer turned the ins on and off normally. Stimulation coverage was reported to be good. The manufacturer representative confirmed that everything was functioning perfectly. The patient was having a difficult time understanding and following instructions.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6041130
• MDR Text Key: 102497462
• Report Number: 3004209178-2016-22094
• Device Sequence Number: 1
• Product Code: LGW
• 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

• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/14/2014
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 08/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/19/2016 Patient Sequence Number: 1