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

Model Number 37601

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Device Overstimulation of Tissue (1991); Burning Sensation (2146); Dizziness (2194)

Event Type  Injury  

Event Description

It was originally reported on (b)(6) 2013 that the patient was feeling really hot in the chest on the left side where the implant was located, and also in the head and back.It was stated that the patient also felt dizzy.This started two weeks prior to the report.It was stated that it could be her menopause, too.The patient also felt that stimulation was too strong and that it made her muscle tense up more than the previous implant.She started at 2.50 v with this system, but in her previous system her range was 0-2.50.About eleven months later it was reported that the patient¿s neck was hot and this started one year ago.The patient was told that her lead was fractured and she was scheduled for device removal on (b)(6) 2014.The patient wanted to know what she could do about the heat and noted that she got the remote, synched with the implantable neurostimulator (ins), and stimulation showed off.The patient had spoken with her healthcare provider (hcp) and the office, but they would not move up the surgery date and they did not have any direction on what she could do in the meantime.Additional information was requested, but was not available as of the date of this report.

Event Description

Additional information received reported that the patient never had therapeutic effect and her implant was not done correctly.The patient had dyskinesias with therapy on, so her implantable neurostimulator (ins) had been off for the past three months to a year.For the past three to six months when the patient walked by the refrigerator or air conditioner her neck felt like it was heating up.The patient then thought it had actually been going on for six months to a year, so it was unclear how long it had been going on.The patient was also having bad urine accidents in her pants during this time.It was noted that the doctor found the broken lead wire last year.The patient¿s surgery was moved up to (b)(6) 2014, but she still wanted it done sooner.The patient outcome was not yet known, so additional information was requested.If additional information is received a supplemental report will be sent.

Event Description

Additional information received reported that the patient developed increased dyskinesia due to advanced parkinson¿s disease and more medication was needed.Impedance testing was performed.The surgeon removed the adaptor, extensions, and leads to prepare for re-implant in a different brain target.The previous target was the subthalamic nucleus (stn) and the neurologist would like to try the internal globus pallidus (gpi) to better control dyskinesia.Follow-up from the manufacturer representative reported an infection without any details or timing.A mri was desired so new leads could be placed.Any further intervention and the patient outcome were not reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant products: product id 37642, serial # (b)(6), product type programmer, patient; product id 64002, lot # n390514, implanted: (b)(6) 2013, product type adapter; product id 3387-40, lot # j0519305v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(6), implanted: (b)(6) 2005, product type extension; product id 3387-40, lot # j0519305v, implanted: (b)(6) 2005, product type lead; product id 748251, serial # (b)(4), implanted: (b)(6) 2005, product type extension.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported the patient¿s leads were broke and had been removed.The patient¿s implantable neurostimulator (ins) was still implanted.The patient stated their refrigerator was bothering them and they wanted to make sure the ins was shut off like their healthcare professional told them.

Manufacturer Narrative

(b)(4).

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3973603
• MDR Text Key: 4752790
• Report Number: 3004209178-2014-13837
• Device Sequence Number: 1
• Product Code: MHY
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/15/2014

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: 11/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 08/01/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/26/2014; 10/08/2014; 04/16/2015
• Date Device Manufactured: 06/04/2013
• 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