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	03/28/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional (hcp) via a manufacturer representative reported during the surgery, it was found the resistance was low, 29, and the hcp had to replace a new one to complete the surgery successfully.No symptoms were reported.There were no further complications reported and/or anticipated.
Additional Manufacturer Narrative
Product analysis #225658925: analysis information -- 2017-05-26 14:01:42 cst pli# 10 product id# 3389s-40 due to the reported complaint, an impedance test was performed in 0.9% saline solution and good impedances were observed using an n'vision clinician programmer.Electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Concomitant medical products: product id neu_stylet_acc, lot# unknown, product type: accessory.
Event or Problem Description
A healthcare professional (hcp) via a manufacturer representative reported during the surgery, it was found the resistance was low, 29, and the hcp had to replace a new one to complete the surgery successfully.No symptoms were reported.There were no further complications reported and/or anticipated.No new event information received.No new information.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received from the manufacturer representative reported that the surgery was a success, with no patient impact as a result of the low impedances.It is unknown what design of the depth stop tip was in use.No further complications are anticipated.
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: 6529354
• Report Number: 2649622-2017-04883
• Device Sequence Number: 13532145
• 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): 06/23/2017

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: VA18A7C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 06/21/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 06/07/2017; 06/23/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR