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	12/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from the healthcare professional (hcp) via the manufacturer¿s representative regarding a patient with an implantable neurostimulator (ins).It was reported that during the implant procedure, intra-operative impedances were high (open circuit >40,000 ohms) on combinations with contact 2 on the lead.There were no environmental, external, or patient factors that may have led or contributed to the issue.The surgeon declined to troubleshoot and to take action.The issue was not resolved at the time of report and the lead remained implanted in the patient.No surgical intervention had occurred and none were planned.Relevant patient medical history included parkinson¿s.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Follow-up information was received from the hcp via the rep reporting that the cause of the high impedance was not determined.The rep reported that the high impedances were not resolved as the hcp chose not to troubleshoot.The rep reported that the extension and battery placement was scheduled for (b)(6) 2018.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received.It was reported they didn't want to test the impedances because they get high.The high on electrode two changed position of the lead and the impedances went back down.No further complications were reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the manufacturing representative (rep) indicating they did not know if the impedances were resolved and would not know until the ins and extensions were placed.
Additional Manufacturer Narrative
Additional review indicates that information from manufacturer¿s report #3007566237-2017-05156 was already reported in this report (#2649622-2017-15596).Any additional information regarding that event will be submitted as a supplemental submission to this 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 an implantable neurostimulator (ins).It was reported there was an open circuit today on electrode two >40,000.The healthcare provider (hcp) didn't want to test impedances again or change anything because they said that the impedances always seemed to normalize and they didn't trust the values.Stage 2 shows the impedances were normal.No patient symptoms or further complications were reported as a result of this event.On 2018-01-03: follow-up information was received from the hcp via the rep reporting that the cause of the high impedance was not determined.The rep reported that the high impedances were not resolved as the hcp chose not to troubleshoot.The rep reported that the extension and battery replacement was scheduled for (b)(6) 2018.No further patient complications have been reported as a result of this event.

• 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: 7105550
• Report Number: 2649622-2017-15596
• Device Sequence Number: 13624668
• Product Code: MHY
• UDI-Device Identifier: 00643169516571
• UDI-Public: 00643169516571
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/10/2018

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: 06/20/2020
• Device Model Number: 3389S-40
• Device Catalogue Number: 3389S-40
• Device Lot Number: VA1JQK8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 12/11/2017; 01/10/2018; 01/10/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 12/12/2017; 01/03/2018; 01/10/2018; 01/10/2018
• 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: 63 YR
• Patient Weight: 58