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

Model Number 37612

Device Problems Electromagnetic Interference (1194); Energy Output To Patient Tissue Incorrect (1209); Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574); Charging Problem (2892); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)

Patient Problems Bruise/Contusion (1754); Chest Pain (1776); Device Overstimulation of Tissue (1991); Pain (1994); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Electric Shock (2554)

Event Date 11/21/2017

Event Type  Injury  

Manufacturer Narrative

Date of event was reported as follows: loss of therapy/no coupling bars during charging issue was unknown; mammogram was about 2 weeks ago.Date of event was reported as follows: loss of therapy/no coupling bars during charging issue was unknown; mammogram was about 2 weeks ago.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the manufacturer¿s representative regarding a patient with an implantable neurostimulator (ins) for deep brain stimulation.It was reported that the patient felt a shocking/jolting sensation with stimulation on or off which started on (b)(6) 2017.Impedances were normal and there were no dramatic changes compared to previous impedance testing.It was noted the patient had a mammogram done about 2 weeks ago.In addition, the manufacturer¿s representative reported the patient had a loss of therapeutic effect and that the device cannot take a charge/no coupling bars.There were no falls or trauma reported that could be related to the issue.There were no further complications reported or anticipated.

Manufacturer Narrative

Date of event was updated and is an approximate.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 were able to achieve 4 efficiency bars when they met with the patient on (b)(6).On (b)(6), the patient called saying that she can only achieve 2 bars.The patient started to first experience difficulty charging one month prior.The pocket was reported to be palpated and they could not recreate the shocking/jolting.Shocking and jolting always happens during impedance tests.The rep could located 4 efficiency bars but was extremely sensitive with movement.The voltage of the patient was lowered so she feels better in her head and there is no tingling but her tremors are more pronounced now that the voltage has been dropped some.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative stating the patient felt her extension wire was tight in the back of her head which began after the mammogram.The caller stated she thinks the patient had an "electrical leak".Caller stated she thinks the ins might have migrated down in the pocket site which is why the extension wires are feeling so tight.The caller stated the surgeon did not want to go back and do exploratory surgery but they planned to have the neurologist push it back to the surgeon.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient.Patient reported that they were not getting maximum benefit fromm ins therapy like they were before, further stating shaking in right hand, reacting negatively to a lot of things happening in the brain.Patient reported funny feelings in their head like too much electricity.Prior to the report, patient met with the health care professional (hcp), surgeon and manufacturer's representative (rep), and it was stated that programming was performed , hcp turned ins off and turned it back on a low setting between 50-75 when recharging which helped with the electricity in the patient's head.Patient reported they felt a terrible shock during the programming session while the doctor was trying to adjust the ins, and it was reviewed that they may have been part of the process to check/program the device.An x-ray mammogram was reported to be related to this issue.Patient reported that during the mammogram, their ins was hit and they had a black and blue spot on the chest after, further stating that they think the adverse events reported were related to the mammogram.Patient was redirected to follow up with hcp for continued troubleshooting if desired.Patient reviewed that the surgeon did not wish to operate unless necessary due to the patient's age.Patient reported that programming changes had helped and they could live with their current symptoms since they are retired, but was not getting the maximum benefit they were before.Patient also reported a heart attack sensation.Patient reported chest pain from the ins area (left side) radiating to the left and kind of felt like it was their heart, further stating the first occurrence lasted 30 minutes, patient went into hospital and had a heart work up and nothing was wrong, second occurrence lasted 5 minutes ,patient had a heart monitor they used and everything was normal with their heart.Patient also reported pain/ discomfort at the ins site.Patient was redirected to follow up with hcp to assess the ins/lead for this reaction.It was also stated that the ins had to be implanted on the left side as patient had a mastectomy on the right side so the ins could not be placed on that side.No further patient complications were reported/ anticipated as a result of this event.

• 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: 7139839
• MDR Text Key: 95624482
• Report Number: 3004209178-2017-26502
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Date Device Manufactured: 05/18/2016
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 86 YR