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

Model Number 3387S-40

Device Problems Break (1069); Difficult to Insert (1316); Shipping Damage or Problem (1570); Material Twisted/Bent (2981)

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

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider via a manufacturer representative (rep) regarding a dbs lead.It was reported that a lead was opened and measured using ao measuring tool, the distal tip of the lead was slightly bent and would not insert into cannula.Opened new lead and worked fine and had a good outcome.No environmental/external/patient factors may have or contributed to the issue.No diagnostics/troubleshooting was performed.The issue is reported to be resolved.No symptoms were reported.The lead will be returned for analysis.No further complications were reported or anticipated with this event.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

No additional information was received.

Manufacturer Narrative

Analysis of the lead (lot # va1ncj8) revealed that the distal end of the lead was bent new out of box.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• 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: 8061602
• MDR Text Key: 127054064
• Report Number: 2649622-2018-18494
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169752290
• UDI-Public: 00643169752290
• 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,Followup
• Report Date: 01/16/2019

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: 09/27/2020
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1NCJ8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 11/16/2018; 01/10/2019
• Supplement Dates FDA Received: 11/19/2018; 01/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2018
• 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