MAUDE Adverse Event Report: MPRI DEEP BRAIN STIMULATION 8-4 EXTENSION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 3708660

Device Problems Shipping Damage or Problem (1570); Insufficient Information (3190)

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

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: neu_set_screw, product type: accessory; product id: neu_set_screw.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp), via a manufacturing representative (rep), regarding a patient with an implantable neurostimulator (ins).It was reported that the screw in the extension block was defective.The screwdriver could not be seated into the set screw.The screw was replaced with a screw from the extension kit.No environmental, external, or patient factors were reported to have contributed to the issue.The issue was resolved at the time of the report.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare provider (hcp), via a manufacturing representative (rep), indicated the screw was discarded and would not be returned for analysis.No further complications were reported or anticipated with this event.

• Brand Name: DEEP BRAIN STIMULATION 8-4 EXTENSION
• 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: 8764771
• MDR Text Key: 150155152
• Report Number: 2649622-2019-11653
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169449152
• UDI-Public: 00643169449152
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2023
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2019
• Date Device Manufactured: 03/15/2019
• 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
• Patient Age: 48 YR