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

Model Number	3387S-40
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Receipt by User (1570); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product id: 924256, lot# 082224416a, product type: accessory.
Event or Problem Description
A manufacturer representative (rep) reported that they were doing a new implant on (b)(6) and the lead tip, specifically the silicone piece distal to 0 contact, appeared crooked/bent out of the box.It was stated that it didn't look like other leads and a different lead that looked "normal" was used.It was further noted that during the case they also had a defective stim-loc in which the titanium screw was stripped, which "happens a lot" and the surgeon has seen several times.A different kit with a new screw was used as well.The patient's indication for implant is unknown.
Additional Manufacturer Narrative
The lead 3387s-40 stimloc dbs, lot # va1bdyv has the appearance of the tip being slightly off-centered in one direction, however, it is within the acceptable visual inspection criteria.The lead was electrically okay.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.
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: 6185349
• Report Number: 2649622-2016-16427
• Device Sequence Number: 16372360
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/03/2017

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: 08/24/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1BDYV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2017
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided; 02/02/2017
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 02/03/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1