MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	37085-60
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device used for off label indication.This device was used with a non-medtronic ins.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient with an implanted neurostimulator (ins).It was reported that the patient was having a lack/loss of stimulation benefits.Their lead had a short circuit when tested intra-operatively, and their extension was replaced.The issue was not resolved at the time of the report.No further complications were reported as a result of this event.Refer to manufacturer report #6000153-2018-00003 for details pertaining to the related reportable event.
Additional Manufacturer Narrative
Analysis found that there was no anomaly.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): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 7301135
• Report Number: 6000153-2018-00004
• Device Sequence Number: 1823524
• Product Code: MHY
• UDI-Device Identifier: 00613994353528
• UDI-Public: 00613994353528
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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: 09/01/2015
• Device Model Number: 37085-60
• Device Catalogue Number: 37085-60
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 04/05/2018
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 04/19/2018
• 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