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

Model Number 37712

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)

Patient Problems Pain (1994); Seizures (2063); Loss of consciousness (2418); Irritability (2421); Electric Shock (2554)

Event Date 01/02/2017

Event Type  Injury  

Manufacturer Narrative

References the main component of the system and other applicable components are: product id: 39286-65, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.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 health care professional (hcp) and a manufacturer representative regarding a patient who was implanted with a neurostimulator for non-malignant pain and postlaminectomy pain.It was reported that impedances were not measured, the implant was on, and it was unknown if there were any recent medical test/ emi/ environmental factor.The patient was at work when they passed out due to the stimulator shocking the patient.The patient was unable to provide any information at this time as the patient was in a considerable amount of pain and was combative when they came to after passing out.It was believed that the patient may have had some sort of seizure.Because of this the patient had been given a lot of medication that might have been ¿benzo¿ to help the patient calm down.The patient was then reported to not be in a lot of pain when they had come in but the patient could be heard in the background of the call.The patient was reported to experience their current symptoms when the implantable neurostimulator (ins) was off.It was attempted to have a nurse do a physician mode recharge (pmr) but they could not see the 60 minute timer.Therefore, the nurse was taught how to use the stimulation off button and confirmed that they say the icon for stimulation being off.There was not a clinician programmer present to interrogate the ins.The manufacturer representative was on their way to the hospital to check on the patient.The patient was currently being sent for a ct scan.Troubleshooting did not appear to be helping the patient at the time of the call.The patient had a shocking sensation all over their body and a potential seizure at the hospital.This was sudden on (b)(6) 2017.Additional information was received later from the manufacturer representative when they were able to see the patient at the hospital to check the system.The clinician programmer showed the ins was turned off and at 0.8v.Everything appeared normal.Impedance testing was done at 0.7v and gave values between 621-900 ohms.The manufacturer representative confirmed that stimulation was off and turned the voltage down to 0.0v.The patient was still experiencing the shocking sensation.The patient stated that a lightning strike had been confirmed nearby where they worked.The patient asked to have the ins and possibly the lead removed.The patient did not have a managing hcp.The manufacturer representative had no additional information on 2017-01-04 regarding this event.

Manufacturer Narrative

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

• Brand Name: RESTORE ULTRA
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6244236
• MDR Text Key: 64578885
• Report Number: 3004209178-2017-00681
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842343
• UDI-Public: 00613994842343
• Combination Product (y/n): N
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

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: 05/14/2013
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2017
• Initial Date FDA Received: 01/11/2017
• Supplement Dates Manufacturer Received: 01/02/2017
• Supplement Dates FDA Received: 09/28/2017
• Date Device Manufactured: 06/15/2012
• 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): Hospitalization; Other
• Patient Age: 41 YR