MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	37612
Medical Device Problem Codes	Charging Problem (2892); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: product id: 37791, product type: recharger.
Event or Problem Description
Information was received from a healthcare professional (hcp) regarding a patient implanted with a neurostimulator (ins) for essential tremor and movement disorders.It was reported that the patient was unable to charge the ins.The patient was getting 2-3 coupling bars.They waited a few days to try recharging again, and despite repositioning the antenna and trying multiple times for 2.5 hours, they couldn¿t get any coupling bars.The ins was reportedly at 75%.It was noted that the implant site was still healing but looked normal.A replacement antenna was sent to try to resolve the issue.No further complications were reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed fdc code (b)(4) replaces previous codes of type if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of the ins (serial no.(b)(4)) found no significant anomaly.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 PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6580854
• Report Number: 3004209178-2017-10719
• Device Sequence Number: 889324
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/28/2017

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: 09/28/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2017
• Supplement Date Received by Manufacturer: 08/02/2017; 08/02/2017; 09/27/2017
• Initial Report FDA Received Date: 05/21/2017
• Supplement Report FDA Received Date: 08/08/2017; 09/07/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR