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

Model Number 37603

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

Patient Problem Skin Erosion (2075)

Event Type  Injury  

Event Description

It was reported the lead and extension connection eroded behind the patient¿s ear.The extension was removed to prevent infection.No infection was present.No troubleshooting was done.The manufacturing representative thought the implantable neurostimulator (ins) was possibly removed, but they were unsure.The cause of the erosion was unknown.The patient was to be re-implanted in the near future.

Manufacturer Narrative

Concomitant medical products: product id: neu_ins_stimulator, serial# (b)(4), , product type: implantable neurostimulator.Product id: neu_unknown_lead, product type: lead.Product id: neu_unknown_lead, product type: lead.Product id: neu_unknown_ext, product type: extension.Product id: 3708660, serial# (b)(4), implanted:(b)(6) 2013, product type: extension.Product id: 3389s-40, lot# v975264, implanted:(b)(6) 2013, product type: lead.Product id: 3389s-40, lot# v975264, implanted:(b)(6) 2013, product type: lead.(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: 4934940
• MDR Text Key: 6011858
• Report Number: 3004209178-2015-13941
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2015
• Initial Date FDA Received: 07/23/2015
• Date Device Manufactured: 04/22/2013
• 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: 00062 YR