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

Model Number 37601

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Swelling (2091); Discomfort (2330); Complaint, Ill-Defined (2331); Impaired Healing (2378); Neck Pain (2433); Skin Inflammation (2443)

Event Type  Injury  

Event Description

It was reported that the lead up a patient¿s neck was ¿quite sore all the time¿ and was ¿swollen part of the time.¿ it was noted that the patient was wondering if there was a problem with the wires or if he was allergic to it.It was reported that it started a couple of months prior to the report and it had been painful for three or four days prior to the report.The reporter stated that the patient¿s physician said that it ¿happened sometimes.¿ it was reported that the patient had an appointment scheduled to see his physician on (b)(6) 2013.Additional information received reported that the patient is still having concerns with their device but has not sought further help.It was noted that the patient had an appointment on 2013 (b)(6).It was later reported that there was an infection.The patient had been treated for an infection at the lead wire sites in the neck.The patient was taking a second round of antibiotics and the areas that appeared to be infected had not seemed to be getting any better.It was noted that there were 2 sites and they were the entry points in the patient¿s neck where the lead wires had been inserted.Since the implant, the patient had had ¿scabbing¿ at those two spots and they had never completely healed.It was noted that on (b)(6) 2014, the sores had appeared to be ¿boiling up¿ and looked bad.The caller was concerned that it was the lead wires themselves that caused the infection.The healthcare professional was aware of the sites and was treating the patient with a second round of antibiotics.The patient had had pain in the neck area around the lead wires for over a year prior to (b)(6) 2014.Patient¿s friend or family member was unsure what the next step was for the patient¿s leads or if they would need to be removed.Patient had a follow-up appointment scheduled for (b)(6) 2014.It was noted that all wires were on the patient¿s right side.Patient was reprogrammed on (b)(6) 2014 and (b)(6) 2014.It was further noted that about one and a half months prior to (b)(6) 2014, the patient had a mole removed that was near the lead entry points and the day prior to that the surgeon removed one of the ¿scabbed areas¿ with a razor.On (b)(6) 2014, the ¿lower lead entry point¿ appeared ¿puffy and boil like.¿ it was further noted that the patient could feel the wires in his head sticking out of his skull.The healthcare professional felt the patient¿s skull in that area but had not felt what the patient had described feeling.

Manufacturer Narrative

Product id 3389s-40, lot# v798530, implanted: 2012 (b)(6); product type lead product id 3550-05, lot# n308199, implanted: 2012 (b)(6); product type accessory product id 3389s-40, lot# v798530, implanted: 2012 (b)(6); product type lead product id 3550-05, lot# n308199, implanted: 2012 (b)(6); product type accessory product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 37085-60, serial# (b)(4), implanted: 2012 (b)(6); product type extension product id 37642, serial# (b)(4), product type programmer, patient product id 3389s-40, lot# v798530, implanted: 2012 (b)(6); product type lead product id 3389s-40, lot# v798530, implanted: 2012 (b)(6); product type lead.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id: 3550-05, lot# n308199, implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: accessory.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension.(b)(4).

Event Description

Additional information received reported that both extensions and the implantable neurostimulator (ins) were explanted.The patient had extension erosion, approximately a half inch in length, in two spots at the parietal and occipital areas.The patient had drainage, what the patient's wife called to be pus, and incisional wound opening at the extension location.The surgeon did not see pus, but cultured both sites for infection.It was noted that the issue was not due to product issues and the surgeon was uncertain why the erosion occurred.At the time of the report the patient was alive with no injury and no physician follow up was required.

• 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: 3721023
• MDR Text Key: 4233920
• Report Number: 3004209178-2014-05458
• 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
• Report Date: 03/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2014
• Date Device Manufactured: 03/02/2012
• 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 Outcome(s): Required Intervention
• Patient Age: 00074 YR