MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Unintended Collision (1429); Overheating of Device (1437); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Abdominal Pain (1685); Undesired Nerve Stimulation (1980); Swelling (2091); Burning Sensation (2146); Discomfort (2330)

Event Date 03/09/2016

Event Type  malfunction  

Event Description

The consumer reported that they were in a bad car accident on (b)(6) 2016, where he was rear-ended but did not move until a paramedic put him on a stretcher.The patient instantly felt the device pinching him in the inside, like it was being pushed further in him and he felt pain in the stomach.The implantable neurostimulator (ins) was located in his back, but the pain was going in his stomach.The patient's back was still swollen from the accident.The patient noted that the battery inside of him was also hot.The patient went to the er on (b)(6) 2016, but they did not know anything about the device.The hospital refused to give the patient any morphine for his pain, so he went home.The patent clarified that the pain was "ridiculous." about 9 days later, it was noted that the burning in the patient's stomach from the battery still gave him a very hot sensation.The patient's back was still swollen from the accident.The patient felt the burning feeling every time he sat in the care seat and the belt was "exactly on top of the battery in my stomach every time." the patient's pain doctor was notified of the event.The patient noted that he would stay uncomfortable until his physician's appointment on (b)(6) 2016.Indications for use include spinal pain.

Event Description

Additional information received reported that the patient still had the hot burning pain from the battery.The patient had an mri scheduled and was working on scheduling an appointment with the physician.The patient had stomach and back pain since (b)(6) 2016, following a rear ended accident.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5555129
• MDR Text Key: 42164654
• Report Number: 3004209178-2016-06309
• Device Sequence Number: 1
• Product Code: GZB
• 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: 05/11/2016

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: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 04/07/2016
• Supplement Dates Manufacturer Received: Not provided; 04/18/2016
• Supplement Dates FDA Received: 05/11/2016; 09/21/2017
• Date Device Manufactured: 11/03/2014
• 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: 00039 YR