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

Model Number	3389S-40
Medical Device Problem Code	Low impedance (2285)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator.It was reported that during a deep brain stimulation (dbs) lead implantation surgery on (b)(6) 2017, the resistance/impedance values were found to be too low; 0<(>&<)>1= 12ohms, 0<(>&<)>2= 12ohms, 0<(>&<)>3= 24ohms, 1 <(>&<)>2= 11ohms, 1<(>&<)>3= 23ohms, 2<(>&<)>3= 23ohms.A new lead was used to successfully complete the surgery.The patient's status is currently well.No symptoms were reported.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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
Analysis of the lead 3389s-40 stimloc dbs (lot # va180d9) and the stylet confirmed the allegation by showing that there was damage at the depth stop site of both devices, causing the issue.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.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: 6493807
• Report Number: 2649622-2017-04858
• Device Sequence Number: 19165358
• Product Code: MHY
• UDI-Device Identifier: 00643169313538
• UDI-Public: 00643169313538
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 07/14/2017

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: 05/16/2019
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA180D9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Initial Date Received by Manufacturer: 03/18/2017
• Supplement Date Received by Manufacturer: Not provided; 07/07/2017; 07/07/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 06/29/2017; 07/14/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1