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

Model Number	3389S-40
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The company representative (rep) reported it was found the product was not complete when the physician opened the package.The physician had to replace a new one to complete the surgery successfully.No patient symptoms were reported.The patient¿s current status was well.No further complications were reported/anticipated.
Event or Problem Description
Additional information received reported when the doctor opened the electrode package during surgery, he found that the electrode locking device contained two clips, but did not have the cap used for skull repair.
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.
Additional Manufacturer Narrative
Information references the main component of the system and other applicable components are: product id 924256, lot# 082215416a, product type: accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.
Additional Manufacturer Narrative
Analysis of device 924256 stimloc kit (sn (b)(4)), which is part of the lead kit, revealed a stimloc cap was not returned and was considered missing from the stimloc kit.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.
Additional Manufacturer Narrative
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): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6414108
• Report Number: 2649622-2017-02494
• Device Sequence Number: 13585519
• Product Code: MHY
• UDI-Device Identifier: 00643169313538
• UDI-Public: 00643169313538
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/15/2017

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 Expiration Date: 06/02/2019
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA18YE4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; 06/14/2017; 06/14/2017; 06/14/2017; 08/31/2017
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 04/21/2017; 05/16/2017; 05/16/2017; 07/12/2017; 09/06/2017; 09/07/2017; 09/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR