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

Model Number 3387S-40

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

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

Event Date 03/18/2019

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 professional (hcp), via a manufacturing representative (rep).It was reported the lead was viewed as damaged out of the box.It was visible to the eye that the lead was damaged at the zero contact with a slight curve at the distal end.There was no patient contact with the equipment.A new lead was opened and implanted.The issue was resolved at the time of the report.No further complications were reported or anticipated with the event.

Manufacturer Narrative

Analysis of the lead (lot no.Va1w6zy) found that the distal end was bent at the #0 electrode and was outside of the limits of straightness specification.If information is provided in the future, a supplemental report will be issued.

Event Description

No additional information was received.

• 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: 8437370
• MDR Text Key: 139353849
• Report Number: 2649622-2019-04661
• 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
• Report Date: 06/28/2019

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: 10/01/2021
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1W6ZY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 06/27/2019
• Supplement Dates FDA Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2018
• 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: 57 YR