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

Model Number 37601

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

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported the patient had an infection and their implantable neurostimulator (ins) and extensions had been removed.The patient had symptoms of redness at the device pocket.Perioperative antibiotics were administered and the patient did not have meningitis.Antibiotics were given to the patient to treat the infection.A new ins and extension were being implanted on the day of this report.Following the ins and extensions replacement, the patient was doing well.

Manufacturer Narrative

(b)(4): product id 3708695 lot# serial# (b)(4) implanted: (b)(6) 2015, product type: extension.Product id: 3708640, serial# (b)(4) implanted: (b)(6) 2014, (b)(6) 2015, product type; extension.Product id: 3389s-40, lot# va0h307, implanted: (b)(6) 2014, product type: lead.Product id: 3389s-40, lot# va0cs7a, implanted: (b)(6) 2013, product type: lead.Product id: 37642, lot# serial# (b)(4) product type: programmer, patient.(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: 4827495
• MDR Text Key: 18384945
• Report Number: 3004209178-2015-10530
• 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: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2015
• Date Device Manufactured: 01/09/2014
• 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