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

Model Number 37602

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported the patient was having trouble keeping their upper denture in so they had some implants put in.One of the implant came loose on the right side and the connector behind their ear was starting to hurt.The patient asked if this could be a possible infection and they had been put on antibiotics.Follow up with the patient¿s healthcare professional (hcp) indicated the lead came loose and the site became red, swollen and painful.The primary location of the infection was the lead track and the patient did not have meningitis.The cause of the event was not determined.A second surgery was done to fix the site.No antibiotics were given and the site was healing.The patient had recovered without permanent impairment.

Manufacturer Narrative

Concomitant product: product id: 3387-40, lot# l67133, implanted: (b)(6) 1999, product type: lead.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 3387-40, lot# l67133, implanted: (b)(6) 1999, product type: lead.Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 1999, product type: extension.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2001, product type: extension.Product id: 3389-40, lot# j0120728v, implanted: (b)(6) 2001, product type: lead.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient reported that he was still getting soreness around his dbs ( deep brain stimulator) connector behind his right ear.He had been using hearing aids and he had a thing that hooked to the tv and it sent a signal to the hearing aid behind his ear.He noticed he got sore on the connector when he used that device.He was getting drainage out of connector.Drainage started when he got the dental infection and was still going on.A day prior to the report, the patient saw his hcp( health care provider) about the soreness and swollenness of dbs connector area behind his right ear and hcp determined that there was no infection with patient's dbs system.

• 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: 4770796
• MDR Text Key: 21839311
• Report Number: 3004209178-2015-09087
• 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,consumer,health profess
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2015
• Date Device Manufactured: 09/16/2013
• 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: 00077 YR