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

Model Number	97754
Medical Device Problem Codes	Failure to Interrogate (1332); Device Displays Incorrect Message (2591); Charging Problem (2892); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Response, Decreased (2271)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturing representative regarding a patient with an implantable neurostimulator for non-malignant pain, post lumbar laminectomy syndrome.It was reported that the desktop charger had a broken connector pin and the manufacturing representative would not inspect the recharger for damage.The recharger was unable to charge normally.No patient injury was reported.No further complications were reported or anticipated.Additional information: it was reported that a patient can't charge her ins because all she gets is the reposition antenna screen on the recharger.Patient stated that she had called her manufacturing representative (rep), about the reposition antenna issue.Patient stated that her connector pin had broken previously and the rep had called patient services for her and she was sent a replacement desk top charger (dtc) that she received friday ((b)(6) 2017) and patient said she told the rep that she received the replacement dtc, but the replacement didn't resolve the issue of the 'reposition antenna screen' she was seeing.Patient said that the rep told her to call to get a new recharger and told her that he would meet up with her this thursday at the doctor's office on (b)(6) 2017 but didn't see the rep, because he had left early so she had most recently seen him on (b)(6) 2017.Last time the patient had stimulation was on (b)(6) 2017.The patient also stated it had been about (b)(6), almost a month now since she was last able to successfully charge her ins.The patient is not able to communicate with another external devices.The patient is in pain.The patient was redirected to follow up with healthcare professional (hcp) to address likely overdischarge.It was also reviewed with the patient that once the ins was jump started the recharger should work to charge the ins, but if this didn't resolve issue for patient to call back and repairs can replace recharger.Patient stated that she had just spoken to rep and he said he would see patient this thursday, but patient said she was going to call her doctor right now to set up an official appointment.No further complications were reported.No additional patient symptoms were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No additional supplementals required unless additional information received indicates reportable event.[refer to manufacturer report #3004209178-2017-22043 for details pertaining to the reportable related event.].

• 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: 6880240
• Report Number: 2182208-2017-01454
• Device Sequence Number: 16331444
• Product Code: LGW
• UDI-Device Identifier: 00643169109469
• UDI-Public: 00643169109469
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/18/2017

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 Model Number: 97754
• Device Catalogue Number: 97754
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR