MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problem Failure to Deliver Energy (1211)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

Note that information references the main component of the system and other applicable components are: product id: 3387s-40, lot# va0jhdy, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0jsnq, implanted: (b)(6) 2015, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37651, serial# (b)(4), product type: recharger.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer reported via a manufacturer representative that they did not feel therapy had helped them to restore their health.The patient continued to feel the same symptoms they had pre-implant and they had a lot of pain.The symptoms were due to the patient's disease.Prior to the disease, the patient was a bus drive and then a bus assistant.Due to the deterioration of the disease, the patient now washes buses.The patient lives alone and depends on what they earn at work and the support of their siblings.The patient had always been looking for more help and had multiple complaints.The implanted system was okay and the patient tolerated stimulation of the gpi above 5v.The patient had more than 50 percent benefit since implant and they had improved with neuromodulation.If the implantable neurostimulator (ins) is turned off, the patient presents violent movements and severe pain.The ins had turned off once and the cause was unknown.No information about the cause, diagnostics, or troubleshooting was reported.No actions or interventions were taken or planned.The patient was alive with no injury.The patient's indication for use is cervical dystonia.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6427822
• MDR Text Key: 70740631
• Report Number: 3004209178-2017-06216
• Device Sequence Number: 1
• Product Code: MRU
• UDI-Device Identifier: 00613994934611
• UDI-Public: 00613994934611
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

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: 09/28/2015
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: 03/23/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 11/12/2014
• 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: 49 YR