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

Model Number NEU_ENS_STIMULATOR

Device Problems Shipping Damage or Problem (1570); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the manufacturing representative (rep) regarding their implantable neurostimulator (ins).It was reported that after opening the package, it was found that the tip of the extension was bent and it could not be used.A new extension was opened and placed to complete the surgery.The patient was in good condition.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), product type: extension.Product id: 3708660, serial# (b)(4), product type: extension.Product id :3708660, serial# (b)(4), product type: extension.An extension was returned but analysis found it was not extension (b)(4).Follow up was conducted with the geo who provided conflicting information stating "it is only the box of the extension (b)(4), and the extension (b)(4) is returned".However, it was determined a miscommunication occurred with the distributer and (b)(4) was determined to be the complaint extension.Analysis of the extension (serial # (b)(4)) revealed no anomaly.The lead was kinked.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An extension was returned but analysis found it was not extension (b)(4).Follow up was conducted with the geo who provided conflicting information stating "it is only the box of the extension (b)(4), and the extension (b)(4) is returned".Further follow up will be conducted.Product id: 3708660, serial# (b)(4), product type: extension.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DBS¿
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8125694
• MDR Text Key: 129080127
• Report Number: 2649622-2018-19775
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2022
• Device Model Number: NEU_ENS_STIMULATOR
• Device Catalogue Number: NEU_ENS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2019
• Date Device Manufactured: 05/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1