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

Model Number	37704
Medical Device Problem Codes	Premature Discharge of Battery (1057); Migration or Expulsion of Device (1395); Battery Problem (2885)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2019
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 friend/family member regarding the patient's implantable neurostimulator (ins) for spinal pain.Information was reported that the caller said it does not work and the little picture of says end of service (eos).There an allegation of dissatisfaction of the longevity of the patient's ins battery.The caller stated the patient saw the eos message on friday((b)(6) 2019), but thought the ins would last like 10 years.The caller also noted that the patient does not use high settings.The caller also noted that the patient has not had any falls, accidents or traumas however the patient did have rhizotomy for tmj 2 weeks ago, but they knew they had the ins turned off for the procedure.The caller then stated the eri occurred about a month ago then went away.The caller also noted that the patient had been with a manufacturing representative (rep) for reprogramming last week on monday or tuesday.The caller was redirected to the patient's healthcare provider (hcp) to discuss the next steps.No further complications were reported.No patient symptoms were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received by the consumer on 2019-aug-16 reporting that the patient saw a manufacturer representative after the patient fell and the device worked.Three days later it was at end of service (eos).It was reported to be loose and floppy.It was noted that no actions had been taken as the patient was waiting on insurance and compensation before they could find a referral for a physician.The patient was in a lot of pain without stimulation.No further complications were reported.

• Brand Name: ITREL 4
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 8847777
• Report Number: 3004209178-2019-14714
• Device Sequence Number: 2563408
• Product Code: LGW
• UDI-Device Identifier: 00643169107809
• UDI-Public: 00643169107809
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2019
• 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: 07/29/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 77