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

Model Number 3387S-40

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/11/2018

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 manufacturing representative regarding a patient who was implanted with a neurostimulator (ins).It was reported that during preparation for the lead and extension connection during stage 2 of the implant (2 weeks after lead implant and during extension/ins implant portion) surgeon was removing distal end lead cover device.While removing boot from the lead cover, the lead cover slipped off end of lead with the distal metal contact still inside the cover.No environmental/external/patient factors contributed to the issue.No diagnostics/troubleshooting was performed.Actions/interventions included the distal contact was recovered by the surgeon from the cover and replaced on the lead end.Distal end of the lead was inserted into proper end of the extension and tightened as normal.Extension connected to the ins and impedance checked.All unipolar readings were below 2k ohms.It is unknown if the issue is resolved.The patient seemed to not be affected and the implant proceeded normally.Unfortunately, explanted lead cap referenced here was disposed of and not recovered post-operatively.No surgical intervention occurred and none is planned.No symptoms were reported.No further complications were reported or anticipated with this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative indicating that no cause was determined.The event seems to be resolved as electrode contact was re-attached to lead distal end, inserted into extension, and implanted.Impedance test was conducted and unipolar contact's were with normal limit.They will see if the distal contact is effective when patient is programmed later this month.The patient is implanted for dystonia.

• 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: 7514739
• MDR Text Key: 108358407
• Report Number: 2649622-2018-08187
• 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: 05/22/2018

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: 06/01/2020
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1JFX5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/22/2018
• Date Device Manufactured: 07/25/2017
• 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: 16 YR