MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3389S-28
Medical Device Problem Code	Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id 3389s-28, lot# va19ed5, implanted: (b)(6) 2017, product type lead.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator (ins).It was reported the patient¿s newly implanted deep brain stimulation (dbs) device was interfering with the patient¿s pacemaker.The pacemaker could not be interrogated.It was unknown how far the implants were apart.Follow-up information was received from the rep reporting that the pacemaker was able to be interrogated after troubleshooting/reset was completed.Details of the troubleshooting were not available.No further patient complications have been reported as a result of this event.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7025312
• Report Number: 2649622-2017-12854
• Device Sequence Number: 1880239
• Product Code: MHY
• UDI-Device Identifier: 00643169516557
• UDI-Public: 00643169516557
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 11/22/2019
• Device Model Number: 3389S-28
• Device Catalogue Number: 3389S-28
• Device Lot Number: VA1GGNY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR