MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 7426

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 7426, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator.Product id: 3387s-40, lot# v550216, implanted: (b)(6) 2011, product type: lead.Product id: 3387s-40, lot# v525542, implanted: (b)(6) 2011, product type: lead.

Event Description

The patient reported that they were "coded" on the table when the second implant was placed on (b)(6) 2011, and the "wires" moved to the left side and went haywire as of an unknown, recent, date.As a result they had pain and other various symptoms including hand curls when the superdome opens, and them not able to move their left arm when they woke up on (b)(6) 2016.The patient also is walking with a limp on their left side, knees are starting to hurt, and have right shoulder pain "for the second time." it was also mentioned that the patient has an allergy to dyes in medication, and that their vein was blown due to an issue not related to a device or therapy.They believe something must have gotten in the "port" because they felt it in their throat.The patient also noted they are going to buy a 9v battery to check the implant, and want to turn it off to use an "aleve patch" which is likely a tens unit.The patient's indication for implant is dystonia.See related regulatory report 3004209178-2016-22970.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOLETRA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6070237
• MDR Text Key: 58930177
• Report Number: 3004209178-2016-22972
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2012
• Device Model Number: 7426
• Device Catalogue Number: 7426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/06/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: 10/06/2016
• Supplement Dates FDA Received: 09/26/2017
• Date Device Manufactured: 11/08/2010
• 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: 50 YR