MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	37612
Medical Device Problem Code	Delayed Charge Time (2586)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2017
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 regarding a patient with an implantable neurostimulator (ins) for movement disorders.It was reported that the patient's implant was taking longer than usual to recharge.Usually the recharge process took 30-40 minutes but this time it had been over an hour and the ins was not fully recharged.The patient had 8 coupling boxes and reported that the ins recharger battery was full.The patient indicated they would follow up with their healthcare provider if the implant battery level did not increase after giving it more time.No patient symptoms or further complications were reported as a result of this event.
Additional Manufacturer Narrative
Correction on device information.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.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• MDR Report Key: 6661908
• Report Number: 3004209178-2017-13519
• Device Sequence Number: 16409752
• Product Code: MHY
• UDI-Device Identifier: 00643169512993
• UDI-Public: 00643169512993
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2017

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 Expiration Date: 10/28/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 06/20/2017; 06/20/2017
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 07/17/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR