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

Model Number 37612

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Adhesion(s) (1695); Chest Pain (1776); Pain (1994); Scarring (2061); Swelling (2091); Therapeutic Response, Decreased (2271); Discomfort (2330); Complaint, Ill-Defined (2331); Neck Pain (2433)

Event Type  Injury  

Event Description

It was reported that six months prior to this report the patient had a revision surgery to correct a ¿bowstring cord¿ problem in their neck.The implantable neurostimulator (ins) was initially implanted in the patient¿s chest and the revision was done to relocate the ins to the abdomen and add two extensions.For the past two months the problem had reoccurred and appeared to be worse than before.The patient had a loss of therapeutic effect, their therapy was in decline, and they were not getting any therapy benefit.At the time of this report the ins was on and the patient had not had any falls or trauma.The wires in the patient¿s neck were pulling and tugging again and they had become very tight.The patient stated it felt like the wire shifted and was pulling in the same area of the neck again.The patient had pain in their shoulder, chest, and neck especially after waking in the morning.The patient¿s pain and discomfort was moderate, but it was increasing on the side where the wire was running to the ins.The patient had been stretching their neck and that seemed to help take the strain off of the cord a little, but it was very painful to do it.The patient stated they had no idea if they were damaging the cord, units, or implants while stretching their neck.The patient had noticed indentations in their head and a bulge where one of the caps and wires was coming loose from the skull.The patient noticed they had swelling in their chest where the old ins and there was a bunching of wire in their abdomen by the ins.The patient had lost 10-15 pounds and they stated that may account for the noticeable signs in their head and stomach.Overall the ins was doing its job and functioned well and the patient felt the benefits outweighed the negatives.The patient¿s healthcare professional (hcp) did not see anything concerning and they thought the scarring around the extension was contributing to the discomfort.The patient¿s main concern was that if the wire continued to stretch, would it cause problems with the vein or artery that crossed their neck or would it pull on the leads in their brain.Almost two weeks later, the patient reported that their ins was not working correctly and there appeared to be a partial or total failure.The patient programmer was not picking up anything and the recharger was sporadic at picking up a signal.The patient was not sure if this was related to the extreme pulling in their neck or the bunching of wires in their abdomen near the ins.The patient was not feeling as much of the benefits and they were concerned that a wire might be loose and the programmer was inoperable.The patient was not able to turn the ins off since the programmer was not recognizing or reading the ins and it did not show any signs of an ins being present.The recharger had been able to connect to the ins just fine at times and had shown the ins was charging and functioning.The patient knew the ins was on as they were feeling some benefit.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, the event will be updated.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# va0gh58, implanted: (b)(6) 2014, product type: lead.Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014,product type: extension.Product id: 3708140, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.(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: 4596445
• MDR Text Key: 5484134
• Report Number: 3004209178-2015-04656
• 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: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/02/2014
• Date Device Manufactured: 09/20/2013
• 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
• Patient Age: 00049 YR