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

Model Number	3389S-40
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Component Missing (2306); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2017
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 healthcare provider (hcp) via a manufacturer representative (rep) regarding a lead malfunction.The rep reported that the lead was bent upon opening the box.The rep reported that a new lead was opened and used instead.No patient involvement reported.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Analysis of the lead (lot no.Va1fj6s) found that the lead was bent at the distal end.Analysis information -- (b)(6) 2017 16:00:10 cst pli# 10 product id: # 3389s-40, below is unedited, system generated text based on the analysis finding code(s) and test results.Analysis confirmed that the distal end of the lead was bent.{electrical testing of the lead determined that continuity was complete and no electrical shorts were observed between circuits.} electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was bent.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id neu_stylet_acc; lot# unknown; product type accessory.Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Device code (b)(4) was coded in error.Conclusion code has replaced code.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: 6803248
• Report Number: 2649622-2017-10126
• Device Sequence Number: 1038778
• Product Code: MHY
• UDI-Device Identifier: 00643169313538
• UDI-Public: 00643169313538
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2017

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: 01/06/2019
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1FJ6S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 08/21/2017; 10/10/2017
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 08/22/2017; 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1