MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 4; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	37704
Medical Device Problem Codes	Failure to Deliver Energy (1211); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	10/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) via a patient with an implantable neurostimulator (ins) for post lumbar laminectomy syndrome and non-malignant pain.The patient was seeing the low ins battery icon on their patient programmer.They have not seen the elective replacement indicator (eri) or end of service (eos) message.The patient could not feel stimulation 3 or 4 weeks ago so they turned the stimulation off.They turned it on today and felt the stimulation come back on but then noticed the low ins battery icon.The patient has never seen this icon before.The loss of stimulation was considered sudden but could be expected given the age of the ins.The rep would follow up with the patient to discuss further.No further complications were reported/are anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the manufacture representative (rep) on 2017-nov-29.The cause of the low battery icon was due to a normal battery depletion and it being at end of service (eos).The implantable neurostimulator (ins) will be scheduled to be replaced as the clinic agreed.No further complications were reported/are anticipated.

• Brand Name: ITREL 4
• Common Device Name: 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
• MDR Report Key: 7067564
• Report Number: 3004209178-2017-24526
• Device Sequence Number: 18855457
• Product Code: LGW
• UDI-Device Identifier: 00643169107809
• UDI-Public: 00643169107809
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: 37704
• Device Catalogue Number: 37704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR