MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37603

Device Problems Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscle Spasm(s) (1966); Electric Shock (2554)

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an implantable neurostimulator (ins) replacement the patient experienced a sudden shocking sensation with heavy muscular contraction on the right side of the body from head to toes, including heavy contraction or right corner of mouth/cheek, and the patient was unable to speak normally for approximately 4-5 minutes after the event.The patient did not feel any pain or heat during the contraction or afterwards.The pocket was not fully open at the time of the shocking, and the surgeon noted they could not see the ins or extension at that time.The surgeon was using a radiofrequency electrosurgical instrument at the time of the event, and the event occurred while the old (almost depleted) ins was still connected to the system.The ins was not turned off prior to the procedure.A patient return electrode was placed on the patient's right upper thigh top.The electrosurgical smoke evacuator and remote switch activator were not in use at the time of the event.It was also noted the surgery took place with patient awake using local anesthetic.The replacement was completed with closure of the battery pocket.After about 5 minutes, the patient felt normal again, and no burning was detected around the ins pocket, nor along extension or lead paths.Impedance check confirmed impedances were in normal range.The patient was implanted for parkinson's disease.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10622609
• MDR Text Key: 209976952
• Report Number: 3004209178-2020-17166
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2013
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Date Device Manufactured: 01/26/2012
• 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: 72 YR
• Patient Weight: 90