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

Model Number 97714

Device Problems Intermittent Continuity (1121); Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Battery Problem (2885); Communication or Transmission Problem (2896)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 12/01/2016

Event Type  malfunction  

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 family member and a consumer regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient had been implanted on (b)(6) 2016 (wednesday).Thursday evening, it ¿kind of turned on¿ and by friday morning the implantable neurostimulator (ins) stopped providing stimulation.Since then, the patient stated that it felt like it was trying to start back up.The patient felt lightning going through them and then it was off, then on, and then off again.The caller reported that they had been told not to charge but they hoped to be able to charge it enough to turn it off officially because currently they through it was trying to turn back on.The callers wanted to know when they would be able to charge.It was also reported that there had been difficulty when first trying to use the patient programmer.It looked like it was having a hard time connecting.The caller had to keep moving it around to find the sweet spot.¿then they got the recharge the ins error.¿ it was clarified that there was loss of stimulation, no stimulation, and intermittent or erratic stimulation.The caller stated that they made programming so that the patient could feel stimulation.There were no known falls or traumas.There was no known electromagnetic interference (emi).When the patient programmer was used to check the ins the ¿rc only-loss of therapy due to low ins battery¿ message was seen.The patient was not able to charge.The caller took a picture of the screen on the patient programmer that shows that the ins needed to be recharged and sent a picture to the manufacturer representative on (b)(6) 2016.The manufacturer representative told them that they should not recharge.The caller had also called the health care professional (hcp) and spoke with the nurse but had not heard back.The patient had an hcp appointment scheduled for next week.It was reported that the issues were known on (b)(6) 2016.Additional information was sent in by the consumer on (b)(6) 2016 reporting that the ins had been placed on (b)(6) 2016 and by the morning of (b)(6) 2016 it had completed died.It was reported that the patient could not charge now because they were still healing as it had only been 4 days since the surgery.The patient was not getting a response about when they will be able to charge in order to turn it on.

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: 6154981
• MDR Text Key: 61896793
• Report Number: 3004209178-2016-25416
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2016
• Date Device Manufactured: 03/11/2016
• 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: 47 YR