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

Model Number 37713

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Therapeutic Effects, Unexpected (2099); Burning Sensation (2146)

Event Date 11/05/2017

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 consumer regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome.It was reported that around (b)(6) 2017, the patient started noticing a sensation in their arms and legs that kind of felt like they were on fire whenever the ins was turned on.It was noted the patient had one cervical lead and one lead at vertebrae t9 and t10.No contributing factors for this event could be identified.The rep mentioned that reprogramming was an option to the patient but the patient did not even want to consider that option.The ins ended up getting turned off as a result.The rep reported that the patient was going to have their doctor remove the ins at the same time they were scheduled to have their pump device revised.No troubleshooting could be performed at the time of the report due to lack of access to the device.No further complications were reported or anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a manufacturer representative from a consumer regarding the patient.It was reported that the manufacturer will not be notified by the physician or patient regarding any further information about the event including patient weight and explant date or device return status.

• Brand Name: RESTORE ADVANCED
• 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: 8048431
• MDR Text Key: 126502982
• Report Number: 3004209178-2018-24933
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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: 10/28/2007
• Device Model Number: 37713
• Device Catalogue Number: 37713
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/07/2018
• Supplement Dates Manufacturer Received: 11/07/2018
• Supplement Dates FDA Received: 11/21/2018
• Date Device Manufactured: 10/11/2006
• 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