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

Model Number 7426

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported, the patient had a mild stroke after implant and the patient never had therapeutic effect.The implantable neurostimulator was removed.No outcome was 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.Refer to manufacturer report #3004209178-2015-04848.

Manufacturer Narrative

Product id 7426, serial# (b)(4), implanted: 2006 (b)(6) explanted: 2006 (b)(6); product type implantable neurostimulator product id 3387-40, lot# v006765, implanted: 2006 (b)(6), explanted: 2006 (b)(6); product type lead product id 748266, serial# (b)(4), implanted: 2006 (b)(6), explanted: 2006 (b)(6); product type extension product id 3387-40, lot# v006765, implanted: 2006 (b)(6), explanted: 2006 (b)(6); product type lead product id 748266, serial# (b)(4), implanted: 2006 (b)(6), explanted: 2006 (b)(6); product type extension.(b)(4).

• 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 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: 4609844
• MDR Text Key: 21172066
• Report Number: 3004209178-2015-04851
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 02/24/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2007
• 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: 02/24/2015
• Initial Date FDA Received: 03/17/2015
• Date Device Manufactured: 03/30/2006
• 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): Other
• Patient Age: 00015 YR