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

Model Number	97754
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 from a consumer via a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).It was reported that the patient's recharger is inconsistent and sometimes it will charge fully, other times their battery will no charge.No further complications were reported or anticipated.No symptoms were reported.Additional information was received from a manufacturer representative.It was reported that the patient¿s appointment was canceled and had not been rescheduled.No further complications were reported or anticipated.Additional information: it was reported that a patient stated it never recharges the whole way.The patient mentioned the programmer batteries were dead and had to replace.Patient services (ps) asked to clarify if the issue was with recharger/ programmer.The patient could not clarify and stated the recharger however kept reverting back to batteries.Ps had patient set up equipment and patient was getting all 8 boxes and was showing half charged according to the patient programmer and recharger.Ps advised to continue to charge and call back if the problem does continue and make appointment with manufacturing representative and have them check log history of recharging history.Patient also stated she usually get 3 boxes, and stated its been this way over a year.No further information.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the patient.It was reported that the patient's charging issue was resolved.The patient stated that she did not wait long enough.No patient symptoms or complications were reported.
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: 6750131
• Report Number: 2182208-2017-01045
• Device Sequence Number: 1539504
• Product Code: LGW
• UDI-Device Identifier: 00643169518971
• UDI-Public: 00643169518971
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/15/2017

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 08/10/2017; 08/10/2017
• Initial Report FDA Received Date: 07/28/2017
• Supplement Report FDA Received Date: 08/15/2017; 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 54