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 Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Charging Problem (2892); Communication or Transmission Problem (2896); Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 37761, serial#: (b)(4), product type: recharger.

Event Description

Information was received via a manufacturer representative from a patient who was implanted with a neurostimulator for post lumbar laminectomy syndrome and spinal pain.It was reported that this event occurred post-operation.It was reported that the patient hadn¿t charged since around (b)(6) 2016 and now could not connect with the implantable neurostimulator recharger or patient programmer.The patient had surgery in (b)(6) 2016 and hadn¿t resumed recharging since then.No actions or interventions had been taken to resolve the overdischarge, but an appointment for a physician mode recharge was to be determined at the time of the report.The issue was not resolved at the time of the report.No surgical interventions were planned or performed at this time.There were no patient symptoms reported.Additional information was received from a manufacturer representative on (b)(6) 2017 reporting that an overdischarge was alleged.The last charge session was (b)(6) 2016 due to non-compliance and an issue with recharging.There was difficulty recharging.In (b)(6) a new product (implantable neurostimulator recharger (insr) ) was sent out but the patient did not have success and gave up.The patient had an unrelated surgery and had put off troubleshooting with the insr until now.It was reported that a manufacturer representative had previously reported.The caller reported that the patient agreed that they were not a good candidate for the rechargeable device.The caller was questioning if the patient had memory issues.The caller noted that in the notes from the post-operative meeting in (b)(6) 2013 the patient had good coupling with 8 bars.The caller reported that the patient no longer wanted another connector pin and wanted the ins replaced with a primary cell battery.The manufacturer representative reported that the patient¿s desktop charger has a bent connector pin.No symptom was reported.The caller had already talked to repair regarding the desktop charger.It was noted by the manufacturer that the desktop charger was not replaced.

Manufacturer Narrative

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

Manufacturer Narrative

Correction as the event is a product problem and an adverse event.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 a consumer.It was reported no steps were taken due to an injury from auto-pedestrian accident.The patient was planning to deal with it soon.No further complications were reported.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6312323
• MDR Text Key: 66839462
• Report Number: 3004209178-2017-02841
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Date Device Manufactured: 07/31/2012
• 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 Age: 84 YR