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

Model Number	3708660
Medical Device Problem Codes	Connection Problem (2900); Device Operates Differently Than Expected (2913); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a health care provider (hcp) via a manufacturer's representative (rep) regarding a patient who was im planted with an implantable neuro stimulator (ins).It was reported that the extension set screw/metal contact was bent, further stating that while the surgeon was attaching the lead to extension , the extension metal contact was moving.The surgeon thought the potential for lead damage or impedances issue could potentially occur.No environmental/patient factors that may have led to or contributed to the issue were reported.A new extension was during the procedure and the issue was resolved.No patient symptoms were reported.No further patient complications were reported/ anticipated as a result of this event.
Additional Manufacturer Narrative
Analysis of the extension, sn (b)(4) found the distal end setscrew was missing.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: DBS¿
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 7601903
• Report Number: 2649622-2018-09981
• Device Sequence Number: 18886465
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P960009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 11/03/2021
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 06/26/2018; 08/08/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/11/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR