MAUDE Adverse Event Report: MEDTRONIC, INC.; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	97754
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Charging Problem (2892); Connection Problem (2900)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the insr, serial # (b)(4), complaint was unverified.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received regarding a patient with an implantable neurostimulator (ins), and it was reported that the patient saw a screen with a picture of a cord, and thinks it might be the "charge the recharger" screen, but was not sure.Additional information received stated that the patient had all the components, and was unable to charge as the arrows did not line up.It was determined the desktop charger was plugged in backwards and the recharger connector was damaged.Patient was issued a new recharger and desktop charger.No symptoms were reported.There were no reported complications and no further complications were expected.Patient was implanted for non-malignant pain.Additional information: information was reported that the patient has never been able to fully charge.The patient received new ins recharger equipment the patient received resolved the issues with the recharger.No further complications were reported.No patient symptoms were reported related to this event.
Additional Manufacturer Narrative
Review of this mdr shows there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirement stipulated in 21 cfr 803.Medtronic, inc.(if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6886497
• Report Number: 2182208-2017-01458
• Device Sequence Number: 16343900
• Product Code: LGW
• UDI-Device Identifier: 00643169585928
• UDI-Public: 00643169585928
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2017

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 Model Number: 97754
• Device Catalogue Number: 97754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 11/03/2017; 11/20/2017
• Initial Report FDA Received Date: 09/22/2017
• Supplement Report FDA Received Date: 11/03/2017; 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 98