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

Model Number 37602

Device Problems Intermittent Continuity (1121); Migration or Expulsion of Device (1395)

Patient Problems Skin Erosion (2075); Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that the patient¿s lead extension started to slide down his skull soon after implant.Eventually it slid off of his skull.Skin erosion was also reported.This was followed by decreased benefit.It was also reported that when the patient was on vacation he felt his device turning on and off.He felt tingling in his arm and leg like when the device was turned on/ off.The patient¿s implant was revised and replaced in 2013.The extension was removed but the lead remained implanted.No outcomes were 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 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension; product id 3387s-40, lot# va00dcw, implanted: (b)(6) 2012, product type: lead.(b)(4).

Manufacturer Narrative

Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension.Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2014, product type: extension.Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; road 31, km. 24, hm 4; ceiba norte industrial park; minneapolis MN 55432
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 4813073
• MDR Text Key: 15972359
• Report Number: 3004209178-2015-10132
• 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,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2019
• Date Device Manufactured: 04/03/2012
• 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