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

Model Number	3387S-40
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2017
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 professional (hcp) via a manufacturer representative (rep) regarding a patient implanted with a neurostimulator (ins) for parkinson's dual and movement disorders.It was reported that during a lead implant surgery, one of the leads had high impedances.The lead was tested multiple times in saline and was never implanted.A new lead was used and resolved the issue.No further complications are anticipated.
Additional Manufacturer Narrative
Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Fdc code is the most up to date code.
Additional Manufacturer Narrative
Analysis of the lead (lot no.Va1fat8) found no anomaly.Product analysis lead lot no.Va1fat8 the returned {device} passed all {functional} testing in the laboratory.No anomalies were identified.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.Result code updated from (b)(4) conclusion code updated from (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
No additional information was received.
Additional Manufacturer Narrative
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: 6556566
• Report Number: 2649622-2017-04918
• Device Sequence Number: 906151
• Product Code: MHY
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup,Followup
• Report Date (Section B): 07/18/2017

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: 10/11/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1FAT8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2017
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: 07/03/2017; 07/13/2017; 07/13/2017; 07/13/2017
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 07/05/2017; 07/18/2017; 10/04/2017; 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR