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

Model Number 37602

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator, product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 3389s-40, lot# v217680, implanted: (b)(6) 2009, product type: lead.Product id: 3389s-40, lot# v129480, implanted: (b)(6) 2008, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 7438, serial# (b)(4), implanted: (b)(6) 2008, product type: programmer, patient.(b)(4).

Event Description

The patient reported an elective replacement indicator (eri) error code on (b)(6) 2015.There was dissatisfaction with implantable neurostimulator (ins) longevity.The patient saw his new health care provider (hcp) a couple months ago and was told that the device should last until (b)(6).The issue was with the left implantable neuro stimulator.The patient was redirected to their hcp to discuss replacement.There were no patient symptoms reported.The indications for use (ifus) were parkinsons dual and movement disorders.

• 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: 5033258
• MDR Text Key: 25887257
• Report Number: 3004209178-2015-16794
• 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
• Reporter Occupation: Other
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• 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: 08/03/2015
• Date Device Manufactured: 04/04/2012
• 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 Age: 00061 YR