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

Model Number	3387S-40
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
Date of Event	03/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 3387s-40, lot# va1elha, implanted: (b)(6) 2017, product type: lead.Product id: 924256, lot# 082219516a, product type: accessory.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
A healthcare provider (hcp) reported via the manufacturer¿s representative (rep) the consumer was bald, so during the implant procedure the ¿stimloc.Raises were above the skull too far.¿ there were no diagnostics or troubleshooting performed related to the issue.In order to resolve the issue the hcp used a drill to grind the skull down a bit in order to recess the stimloc., down into the bone so it didn¿t protrude above the skull, but the issue still wasn¿t resolved.No further complications were reported.Refer to manufacturer report #3012165443-2017-00013 for details pertaining to the reportable related event.
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.

• 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: 6582555
• Report Number: 2649622-2017-04937
• Device Sequence Number: 624675
• Product Code: MHY
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 05/22/2017

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: 12/01/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1ELJN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 10/04/2017
• 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: 52 YR