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

Model Number	3387S-40
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare provider (hcp) via the manufacturer representative (rep) reported that the lead end looked crimped after removing the lead end cap on the date of implant, (b)(6).It was stated that the lead end cap set screw may have not been covering the metal contact when tightened, potentially causing the issue.The lead was still put into the extensions and impedances were checked which showed as normal.No actions or interventions were taken and the issue was resolved at the time of the report.The patient's indication for implant is unknown.
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): NEURO - VILLALBA; call box 6001; villalba PR 00766
• MDR Report Key: 6339954
• Report Number: 6000153-2017-00008
• Device Sequence Number: 19259901
• Product Code: MHY
• UDI-Device Identifier: 00643169313514
• UDI-Public: 00643169313514
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2017

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: 08/05/2017
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA0P59P
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: 01/26/2017
• Initial Report FDA Received Date: 02/17/2017
• Supplement Report FDA Received Date: 09/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 84