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

Model Number 37601

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems Muscular Rigidity (1968); Scarring (2061); Discomfort (2330); Complaint, Ill-Defined (2331); Neck Pain (2433)

Event Type  Injury  

Event Description

Additional information received reported the patient was still having concerns regarding their device or therapy, but they were working with their healthcare professional (hcp) or a manufacturing representative.The patient stated their hcp was using a low level laser to ease scar tissue on the wire from the clavicle to behind the ear.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the lead wire was rigid and it caused the patient¿s neck to be sore and stiff.There was pain in the neck at the extension location.It had been progressively getting worse since (b)(6) 2014 when the patient had gotten the implant.The patient¿s extensions were too tight.There was a lead/extension issue, it was too tight from the lead connection down to the clavicle.No action was required as a result of the event.In (b)(6) 2015 the healthcare professional had done a revision, they had gone in to pull the lead wire up and they had pulled some of the extension wires up in the neck to see if that would loosen the wires to give the patient more slack or loosen the wires, but that had not worked and the patient had a bundle of lead wire protruding under the skin above the clavicle.The patient had a buckled wire around the clavicle.The patient was very thin so he scared easily.The patient had stated that the design for a lead that would not cause scar tissue should be a ¿requirement.¿ the healthcare professional had told the patient that because he was very thin and had little subcutaneous fat the wires had not ¿skude¿ under the skin as well.The healthcare professional also told the patient that the manufacturer needed to coat the extension with nano technology in order to fix the problem.The current extension wire formed scarring which lead to pulling and pain in the neck.Patients with a lot of fat had not experienced the issue but others do.This was becoming a common problem.The cause of the event was determine and was device related.The healthcare professional thought the coating applied to the wire, all of the wires got scarring then tended to cause pulling unless the patient had a lot of fat which acted as a lubricant.The patient had not recovered, symptoms/issue was ongoing.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Concomitant medical products: product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3708695, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3387s-40, lot# va0hyjm, implanted: (b)(6) 2014, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

It was later reported that the patient had a cable in his neck that was too tight and after the healthcare professional made an incision to put the wire up the wire had bundled up like a varicose vein.The patient's chiropractor had used low energy laser to smooth it out about a month after the healthcare professional had made the incision but the cable was tight again.This was occurring daily and there had been no falls or traumas reported that could be related to the issue.The tightness was located at the back of the neck and it had been a gradual change since implant.

Manufacturer Narrative

(b)(4).

• 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 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: 4613200
• MDR Text Key: 5613568
• Report Number: 3004209178-2015-04935
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Date Device Manufactured: 03/26/2014
• 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: 00072 YR