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

Model Number 7426

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

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that the patient never had therapeutic effect.The reporter initially stated that the therapy was turned off "several years ago," but later stated that they tried programming for "several years" and could not find a setting that would provide relief.Thus, the implant was turned off.The reporter wanted to get another programmer so that the device status could be checked, because during a doctor's appointment the implant was on.Five days later it was reported that the patient had an unusual form of parkinson's disease.The patient never responded to the therapy.The implant just turned on from an unidentified magnetic source in the environment.There were no side effects.

Manufacturer Narrative

Concomitant medical products: product id: 7426, serial# (b)(4), implanted: (b)(6) 2005, product type: implantable neurostimulator.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension.Product id: 3389-40, lot# j0527338v, implanted: (b)(6) 2005, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension.Product id: 3389-40 lot# j0455334v, implanted: (b)(6) 2005, product type: lead.Product id: 7438, product type: programmer.(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: 3677325
• MDR Text Key: 4291319
• Report Number: 3004209178-2014-04405
• 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: Physician
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2006
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2014
• Date Device Manufactured: 02/04/2005
• 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