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

Model Number 3387S-40

Device Problems Bent (1059); Shipping Damage or Problem (1570)

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

Event Date 02/07/2018

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 (hcp) via a manufacturing representative (rep) regarding an event with no patient involvement.It was reported that the hcp opened a lead and they noticed the lead tip was bent.They used a replacement and the issue was resolved.No patient symptoms or further complications were reported as a result of this event.

Manufacturer Narrative

Analysis of the lead, va1ks5e found that the lead distal end was bent (new out of box) if information is provided in the future, a supplemental report will be issued.

Event Description

No new information 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: 7280266
• MDR Text Key: 100528974
• Report Number: 2649622-2018-02658
• 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: 03/13/2018

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: 07/03/2020
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1KS5E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2018
• Initial Date FDA Received: 02/19/2018
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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