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); Skin Erosion (2075)

Event Type  Injury  

Event Description

A manufacturing representative reported the patient had the lead on their right side removed due to an infection.The lead had started to erode through the skin around the stimloc.Relevant patient history included parkinson¿s disease and movement disorders.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3389s-40, lot# v893288, implanted: (b)(6) 2012, product type: lead.Product id: 3389s-40, lot# v893288, implanted: (b)(6) 2012, product type: lead.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.(b)(4).

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the manufacturer representative (rep) reported that leads were being re-implanted on (b)(6) 2016 and the implantable neurostimulator (ins) would be re-implanted the following week.

• 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: 4976779
• MDR Text Key: 6083040
• Report Number: 3004209178-2015-15527
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2016
• Date Device Manufactured: 12/08/2011
• 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: 00069 YR