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

Model Number 97714

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

Patient Problems Fever (1858); Myocardial Infarction (1969); Vomiting (2144); Malaise (2359); No Known Impact Or Consequence To Patient (2692); Test Result (2695)

Event Date 05/24/2016

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 patient who was implanted with a neurostimulator for spinal pain and chronic low back pain.The patient had an electrocardiogram 4 weeks prior to the report at her physical that was abnormal.Four weeks after that she thought that she was having a heart attack so she went to the emergency room.They did an electrocardiogram while she was there and it was abnormal.The patient's cardiologist performed an echocardiogram and a stress test in a machine.The patient got sick after the 2nd stress test.The patient had been running a fever of 102.6 degrees fahrenheit and throwing up.

Manufacturer Narrative

(b)(4).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

Follow-up information indicated that patient's heart attack was not related to their device.They stated that they have lupus, and a history of pericarditis from that.It was also reported that the electrocardiograms were not related to their device.Their nausea, vomiting, and elevated temperature were also not believed to be related to the device.The patient stated that they thought the nausea was from an injection they were given for their stress.They noted that they thought they were sick to their stomach due to headaches, but that issue was resolved.The patient mentioned that their device still needs to be charged.They noted that they will try charging once more, and if they can't get it to charge, they will set up an appointment with a manufacturing representative.Additional information indicated that they were able to successfully charge their device.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 5795617
• MDR Text Key: 49577915
• Report Number: 3004209178-2016-14256
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2016
• Date Device Manufactured: 09/16/2013
• 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): Required Intervention
• Patient Age: 73 YR