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 Pocket Erosion (2013); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was originally reported on (b)(6) 2013 the patient was having program issues with their gait and ability to start walking.The reporter stated they wanted to know if there was a deep brain stimulation data base to find possible solutions for their particular issues.Additional information received reported that the implantable neurostimulator (ins) and extensions were explanted due to generator erosion.The patient recovered without sequela.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va07192, implanted: (b)(6) 2013, product type: lead.Product id: 3389s-40, lot# va07192, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from a company representative reported that previous extensions and ins( implantable neurostimulator) explanted on (b)(6) 2015 due to infection.

• 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: 4953266
• MDR Text Key: 6633020
• Report Number: 3004209178-2015-14368
• 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: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2012
• 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