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 Energy Output To Patient Tissue Incorrect (1209); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885)

Patient Problems Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 06/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from the patient¿s friend/family member regarding a patient with an implantable neurostimulator (ins) for occipital neuralgia.It was reported tha the patient was having trouble with their device and the patient had turned stimulation off, but it felt like the battery was actually shocking them.It was reported that leads go to the patient¿s head, but they felt the shocking sensation at the battery site in their hip.The patient turned stimulation off and saw the stimulation off icon.The caller also stated the patient saw a picture of a phone on their recharger but didn't know any further details.No troubleshooting could be done due to a lack of access to the product as the caller was not with the patient during the call.Patient services recommended that the patient call in directly to perform further troubleshooting.It was reported that the event occurred yesterday on (b)(6) 2018.Additional information was received from the patient the next day on (b)(6) 2018, repeating the event details regarding the shocking sensation at the ins site.The patient indicated that the sensation was intermittent.Patient services recommended synching with the patient programmer and it was confirmed they were seeing the stimulation off icon.The patient powered stimulation on and off again and this did not resolve the shocking sensation.The patient stated they already tried this 20 times and were up all night trying to figure it out.The patient clarified the phone message they saw was actually the eri message on their recharger.Patient services reviewed the meaning of eri and the patient confirmed that they had already been working with their healthcare provider (hcp) for planning replacement, but they were waiting for approval.The patient stated they last saw their doctor on monday, prior to the shocking.The patient confirmed they had been charging normally, and noted they last charged three weeks ago and gave no indication of overdischarge.Patient services does not suspect unintended stimulation following overdischarge.The patient mentioned their charge use to last about six weeks, but over the last year it had gone down to three or four weeks.The patient also confirmed when they turn it on and off they could feel it going on and off in their head, where the leads are located.The patient had already contacted their managing physician's office, but they are completely closed today and told them there was no way they could contact the doctor and redirect them to the manufacturer.Patient services recommended the patient seek medical attention as they deemed necessary.The patient stated they were on pain medication and that was not the problem.The problem was that they are ready to cute the battery out.The patient confirmed they are not planning on cutting the device out, but it was driving them crazy.The patient reported shocking onset was sudden and they had never happened in the past.They had not had any falls, traumas or recent medical tests etc.While on hold the patient disconnected.Patient services attempted outbound call back to patient and the line was not in service.No further complications were reported/anticipated.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7661226
• MDR Text Key: 113152358
• Report Number: 3004209178-2018-14908
• 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
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2010
• Device Model Number: 37712
• Device Catalogue Number: 37712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/27/2018
• Date Device Manufactured: 11/20/2009
• 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: 46 YR