MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

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

Event Date 06/14/2018

Event Type  Injury  

Manufacturer Narrative

See report # 3004209178-2018-14186 for other implantable neurostimulator involved in this event.Analysis results for the returned implantable neurostimulator were not available at the time of this report.A follow-up report will be sent when analysis is complete.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 manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the lead was damaged during the extraction procedure on (b)(6) 2018.No environmental/external/patient factor were thought to have led or contributed to the issue.It was reported testing on the lead was done with a testing cable.All contacts showed open circuits.The physician made multiple attempts to resolve the issue by disconnecting/reconnection and testing with the clinician programmer.The physician requested a new extension and battery to try to restore therapy for the patient.The issue was resolved at the time of the report.The patient was alive without injury at the time of the report.No further complications were reported or anticipated.Additional information was received from the manufacturer representative.It was reported the patient requested another battery be opened.It was opened, not used, and returned to the manufacturer where analysis will be performed.It was reported the ins was removed because they were questioning the functionality of battery.The physician requested the battery be tested for functionality due to high impedances.The patient recovered without sequela.Additional information was received from the health care professional (hcp) via the manufacturer representative.It was clarified the explant procedure occurred on (b)(6) 2018 and the re-implant of the extensions and ins was done on (b)(6) 2018.It was reported after dissecting the lead and reconnecting the lead to the extension connection, there were open circuits.The distal end of the lead seemed to be frayed per the physician which was believed to be the cause of the open circuits.

Manufacturer Narrative

Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (rep).It was clarified the hcp requested to switch out the extension first thinking it could have been a faulty extension.Then they requested to try another battery.The damage to the lead occurred while dissecting the leads and removing the boot and disconnection the lead/extension connection during the reimplant.

Manufacturer Narrative

Analysis results of the implantable neurostimulator (serial # (b)(4)) and the extension (serial# (b)(4)) revealed no anomalies.Good impedance was observed.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.

Manufacturer Narrative

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

Event Description

Additional information was received indicating they were having difficulty getting therapy turned back on and the hcp thought it might be a broken lead.It was noted that the rep did a "programming trick" and was able to get it working.It was noted that the last 3-4 months they have been having trouble again with the right stm lead.An oor occurs when they program the right stn lead, this has been an ongoing issue since implant.Impedances were out of range on 0, 1, 8, 10 at greater than 2000 ohms.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7664029
• MDR Text Key: 113234071
• Report Number: 3004209178-2018-15055
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• 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,Followup,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 59 YR