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

Model Number 37711

Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2016

Event Type  malfunction  

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient who was impl anted with a neurostimulator for radicular pain syndrome (radiculopathies).It was reported there was possible corrosion of a battery.The patient was having a battery replacement due to normal end of service (eos).When the hcp went to replace the implantable neurostimulator (ins) he described the battery as looking as though there was corrosion.It was noted the rep was not present for the case.No mris were done with this patient to the knowledge of the rep and non were notated in the patient chart.No troubleshooting was done to the knowledge of the rep.It was noted the issue was not resolved at the time of the report.The patient's status at the time of this report was 'alive with no injury.' no patient symptoms were reported regarding this event.

Manufacturer Narrative

Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESTORE
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5721046
• MDR Text Key: 47289662
• Report Number: 3004209178-2016-12045
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2006
• Device Model Number: 37711
• Device Catalogue Number: 37711
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Date Device Manufactured: 06/05/2005
• 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: 66 YR