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

Model Number 37603

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Discomfort (2330); Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

No information for date of event.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) for parkinson's dual and movement disorders.It was reported that the patient reported shocking/stinging sensations when performing certain movements.It was determined a replacement battery would be the best options as impedances were normal and there was no sign or an open or fractured parts of the system.All information looks normal when device information was pulled.No environmental/external/patient factors led or contributed to the issue.No diagnostics/troubleshooting was performed.Discomfort occurred during all types of activities.Different programming was tried but unsuccessful.The issue is reported to be resolved at the time of this report.The patient reported no shocking or stinging post-op with the new implant.The device will be returned for analysis.No further complications were reported or anticipated with this event.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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 they are unaware when the patient started to feel these symptoms, they had a hard time identifying a starting time.No cause was determined during certain movements.It happened randomly during all kinds of movements.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) (b)(4) revealed the battery had no significant anomalies and the functionality was okay.If information is provided in the future, a supplemental report will be issued.

• 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: 7541301
• MDR Text Key: 109167686
• Report Number: 3004209178-2018-11784
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761088
• UDI-Public: 00613994761088
• 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
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 05/25/2018; 09/17/2018
• Supplement Dates FDA Received: 06/06/2018; 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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 Outcome(s): Required Intervention