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

Model Number	3389S-40
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported via a manufacturing representative that impedances were measured to be abnormal during implant.Impedances were measured to be greater than 40,000 ohms.The lead was replaced so the hcp could complete the surgery.There was no patient symptoms reported.The patient¿s indication for use is parkinson¿s dual.
Additional Manufacturer Narrative
Analysis of the lead (lot #va0xy4x) found the lead body outer insulation was damaged at the depth stop site 2.8cm from the proximal end.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Additional information received reported that preoperative a package abnormality was found before opened, the device was inspected prior to use, and an abnormality was found.The abnormality was described as ¿unable to continue this operation as high electrode resistance was detected in the test.¿ no lead fractures were noted.A different electrode was used to implant and the result was normal.The patient¿s current status was noted as normal and there was no patient impact.Follow-up is being conducted to obtain clarification around the abnormality reported.If received, this event will be updated.
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 company representative reported before the use of the lead electrodes implanted, the resistance test abnormalities and all of the contact resistance values were over 40,000 ohms.There was no information related to the package abnormality.

• 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: 5475666
• Report Number: 2649622-2016-02664
• Device Sequence Number: 11209534
• 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): 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2018
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA0XY4X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2016
• Supplement Date Received by Manufacturer: 03/28/2016; 03/28/2016; 03/28/2016
• Initial Report FDA Received Date: 03/02/2016
• Supplement Report FDA Received Date: 03/02/2016; 03/15/2016; 04/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR