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

Model Number	3708695
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The main component of the system and other applicable components are: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Analysis of the extension serial# (b)(4) found outer insulation to be ok but conductor wires bent 6.8 cm from proximal end.
Event or Problem Description
Information was received from a manufacturers representative regarding a patient who was implanted with a neurostimulator for parkinsons dual and movement disorders.It was reported that upon moving extension from packaging, there was a significant bend in the proximal end.It was added that the physician did not feel comfortable using it and ended up using an existed extension the patient had implanted by tunneling it below the patients rib cage.There were no patient symptoms reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EXTENSION
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6099848
• Report Number: 2649622-2016-13859
• Device Sequence Number: 16317416
• Product Code: MHY
• UDI-Device Identifier: 00613994749123
• UDI-Public: 00613994749123
• 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
• Report Date (Section B): 11/14/2016

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: 10/07/2020
• Device Model Number: 3708695
• Device Catalogue Number: 3708695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/14/2016
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR