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

Model Number 7426

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); Electromagnetic Compatibility Problem (2927)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  malfunction  

Event Description

It was reported the patient's implantable neurostimulators (ins) shut off in a store.The patient did not know exactly when it happened, but it was before november.The patient mentioned doors, arches and an airport.The patient's ins were alright and their healthcare professional (hcp) set them up.The patient took their medicine and did pretty well while having the inss.Follow up with the patient's hcp indicated the inss turned off and on when the patient went in and out of stores.The patient experienced off periods due to their ins being turned off when entering or exiting stores.The patient had recovered without permanent impairment.

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# v079662, implanted: (b)(6) 2008, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 3389s-40, lot# v079662, implanted: (b)(6) 2008, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 7426, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2014, product type: implantable neurostimulator.(b)(4).

• Brand Name: SOLETRA
• 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: 4572025
• MDR Text Key: 20362531
• Report Number: 3004209178-2015-04185
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2009
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2015
• Date Device Manufactured: 10/26/2007
• 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: 00068 YR