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

Model Number 37714

Device Problems High impedance (1291); Overheating of Device (1437); Unable to Obtain Readings (1516)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain and failed back surgery syndrome.It was reported that the patient was having burning and stinging in the pocket area when the therapy is turned on.The patient noted that this happens at night and when they are recharging.The manufacturer representative checked the impedances and 5 contacts on the left lead had impedances of > 20k ohms and on the right lead, 2 contacts had impedances of > 20k ohms (depending on the reference electrodes).The manufacturer representative attempted to program around the specific electrodes and it did not resolve the issue.The patient was receiving therapy in their legs.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep) on (b)(6) 2018.It was reported that the cause of the burning/stinging at the ins site and the high impedances was unknown at the time of the report.To resolve the issue, the rep tried to reprogram around the electrodes, but it didn¿t help.Lastly, it was reported that a surgery was planned to resolve the reported symptoms and device issues, but a date was not yet set.There were no further complications reported or anticipated.

Manufacturer Narrative

Continuation of d11: product id 3778-60 lot# serial# (b)(4) implanted: explanted: product type lead product id 3778-60 lot# serial# (b)(4) implanted: explanted: product type lead section h reflects the main component and other applicable components.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from rep.It was reported that a revision took place today.

Manufacturer Narrative

Additional review indicated the information in mfg report 238156930 is related to this event.Any additional information regarding the event will be sent as a supplemental submission to this report.If information is provided in the future, a supplemental report will be issued.

Event Description

The rep ran impedances and results showed some values were >10000 ohms and some were "xxx".Rep stated not all values were 10000ohms.The rep stated that he thought that the md was going to replace the leads with a paddle and may replace the ins so he was not concerned about the high values.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.It was reported that the cause was not determined and everything looked normal when pocket was opened and explant occurred.

• Brand Name: RESTORE SENSOR
• 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: 7658731
• MDR Text Key: 113027560
• Report Number: 3004209178-2018-14888
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: 00613994610430
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/22/2018

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: 02/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2018
• Date Device Manufactured: 04/04/2012
• 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): Required Intervention
• Patient Age: 54 YR