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); Coma (2417); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that after implant the patient¿s symptoms and pain had not improved.The patient¿s healthcare professional (hcp) told them their pain and symptoms would be relieved.(b)(6) 2012 the patient was in the hospital and they still had symptoms after being reprogrammed several times.The patient was reprogrammed again in (b)(6) 2012, but the symptoms had not improved.(b)(6) 2013 the patient continued to see their hcp, but they did not have a method to help the patient.In (b)(6) 2013 the patient saw their hcp and they told them to take oxcarbazepine to treat the patient¿s spasm.After taking the medication, the patient felt more pain so they stopped taking it.Since (b)(6) 2013, the implantable neurostimulator (ins) had been off and the patient¿s pain was relieved.The patient¿s ¿problem of walking¿ and coma had not occurred again.The patient did have to take sleeping pills to sleep and they wanted to be reprogrammed again.No interventions or outcome were reported regarding this event.Additional information could not be obtained.Should additional information be received the event will be updated.

Manufacturer Narrative

(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: 4243676
• MDR Text Key: 4989642
• Report Number: 3004209178-2014-21328
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2014

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: 04/14/2013
• 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: 10/21/2014
• Initial Date FDA Received: 11/11/2014
• Date Device Manufactured: 10/20/2011
• 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): Hospitalization; Other
• Patient Age: 00055 YR