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

Model Number 3387-28

Device Problems Shipping Damage or Problem (1570); Material Deformation (2976); Insufficient Information (3190)

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

Event Date 07/04/2019

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 health care provider (hcp) via a manufacturer representative (rep).The lead was obviously kinked in the middle with a distorted stylet upon removal from the packaging.The lead was also longer than 28 cm, but the stylet was the correct length.There was about 1 cm at the leading tip of the lead that was floppy.The physician felt the combination of these problems made it unsafe to pass through the guide tube as they couldn't ensure it would follow the tract made by the probe to the desired target.A new lead was used and the issue was resolved.The kinked lead was never implanted.There was no patient involvement, and thus no patient symptoms or complications associated with the event.

Manufacturer Narrative

Revision of analysis of the lead (lot no.Va1utts) updated the finding to no significant anomaly.(b)(4).Based on additional investigation activities.The returned device was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis identified that the the distal end of the lead is bent; however, electrical testing of the lead segments determined that continuity was complete and there were no electrical shorts between the circuits.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The returned lead was subjected to a series of standard tests that include but is not limited to visual inspection and electrical testing.Analysis confirmed the lead was bent 0.6 cm from the distal end.The lead length was 28.4 cm and there were conductors that were slightly stretched between 16.5 cm and 20.0 cm from the proximal end of the lead, due to a bend in the stylet.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: 8787299
• MDR Text Key: 150977375
• Report Number: 2649622-2019-12146
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Model Number: 3387-28
• Device Catalogue Number: 3387-28
• Device Lot Number: VA1UTTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2018
• 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