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

Model Number 3708660

Device Problems High impedance (1291); Shipping Damage or Problem (1570); Connection Problem (2900)

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

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp)via manufacture representative (rep) regarding a patient who was implanted with an implantable neuro stimulator (ins) for essential tremor and movement disorders.It was reported that impedances on all combos with contact 3 were high because the lead could not seat properly in the connector.The surgeon attempted to advance lead in extension and was not able to pass all electrodes through.The surgeon re-opened set screws to make sure all were open enough to pass lead into extension connection but could not.A new extension was opened and re-tunneled, and the issue was resolved at the time of the report.No patient symptoms were reported.No further patient complications were reported/ anticipated as a result of this event.

• 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: 8399295
• MDR Text Key: 138102829
• Report Number: 2649622-2019-03809
• 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
• Report Date: 03/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: 3708660
• Device Catalogue Number: 3708660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/07/2019
• Date Device Manufactured: 10/08/2018
• 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
• Patient Age: 58 YR