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

Model Number 3387S-40

Device Problems Bent (1059); Break (1069)

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

Event Date 10/30/2017

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 manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins).The rep reported that the distal end of the lead was crimped.The rep reported that the lead was found to be crimped upon exposure during the stage 2 procedure on (b)(6) 2017.The rep reported that the lead had been correctly capped with a boot during the stage 1 procedure days earlier.No patient symptoms were reported.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from the health care provider (hcp) via a manufacturer representative (rep).It was reported the physician determined the cause was due to the manipulation of the distal end of the lead after being capped during the stage 1 procedure.Additionally, it was thought that pulling on the cap to expose the distal end of the lead during the stage 2 procedure caused stress on the end of the lead.The distal end of the lead was in excellent condition when initially capped.Due to a lack of options, the physician elected to go ahead and attach the extension and ins and proceed with impedance checks.All impedances were within normal ranges upon completion.No further complications were reported/anticipated.

• 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: 6993868
• MDR Text Key: 91229573
• Report Number: 2649622-2017-12831
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1JSAY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2017
• Date Device Manufactured: 08/07/2017
• 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
• Patient Age: 52 YR
• Patient Weight: 44