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

Model Number 37612

Device Problems Energy Output Problem (1431); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Tingling (2171); Electric Shock (2554)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Dystonia is an off-label indication for activa rc (model no: 37612).Country event occurred in was the (b)(6).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 who was implanted with a neurostimulator (ins) for dystonia.The patient felt weird sensation during certain movements.It was further clarified that the patient feels a tingle throughout the body like when using a vacuum cleaner.Impedances were measured several times including during palpation over parts of the implant.No abnormalities were found, other than an impedance of 2200 ohms on pair c/3 when measured below 3.0 v which resolved after re-measuring the impedances at 3.0 v.Impedances from a month prior to the notify date were also normal.The patient was programmed on c+1- at 5.5 v, 130 hz, 120 microsecond pw on left side (therapy impedance: 1080 ohms) and c+9- at 5.0 v, 130 hz, 120 microsecond pw on right side (therapy impedance: 1020 ohms).No further complications were reported/anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information clarified the tingling/shocking sensation only occurred one time so far while using the vacuum in (b)(6) 2018.The root cause was not determined, but no actions had been taken to resolve the event.No further complications were reported.

Manufacturer Narrative

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: 7533105
• MDR Text Key: 109377523
• Report Number: 3004209178-2018-11480
• Device Sequence Number: 0
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

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: 02/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 06/18/2018; 08/08/2018
• Supplement Dates FDA Received: 07/11/2018; 10/05/2018
• Date Device Manufactured: 03/21/2016
• 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