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

Model Number 37612

Device Problems High impedance (1291); Overheating of Device (1437); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Erythema (1840); Burning Sensation (2146); Complaint, Ill-Defined (2331); Neck Pain (2433); Electric Shock (2554)

Event Date 09/10/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# v433170, implanted: (b)(6) 2010, product type: lead.Product id 3387s-40, lot# v444283, implanted: (b)(6) 2010, product type: lead.Product id 3708640, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: extension.Product id 3708640, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2015, product type: extension.Product id 37651, serial# (b)(4), product type: recharger.Product id 37761, serial# (b)(4), product type: recharger.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

The healthcare provider (hcp) reported that the patient experienced intermittent shocking and right facial pulling.Both started on (b)(6) 2015 per the patient's mom.The mom notified the clinic on (b)(6) 2015 of the symptoms.The patient was seen in clinic on (b)(6) with x-rays.She complained of right neck electrical shocks and pain about every 30 minutes.There was no erythema or tenderness around the system.A mri was taken and the patient had a follow-up visit on (b)(6) 2015 with continuing electrical shocks every 30 minutes.At the follow-up she also complained of redness and increasing heat while recharging; her chest got warm when recharging.There was no event noted that led to the shocking.An impedance test revealed no high impedances and there was no shocking with the device off.However, it was later noted there were high impedances measured on both extensions.A revision was performed on (b)(6) 2015.The implantable neurostimulator (ins) and extensions were replaced.This patient was nonverbal, communicating with her feet, with torsion dystonia and spasmodic torticollis.The patient's indications for use were dystonia and movement disorders.Refer to user facility report #1750369203-2015-00003.

Manufacturer Narrative

Analysis of the neurostimulator, serial #(b)(4), found it functionally okay with insignificant anomalies.A heat test was p erformed with the explanted ins and a control device; no anomalies were observed.

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 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: 5246572
• MDR Text Key: 32034578
• Report Number: 3004209178-2015-23335
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2013
• 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): Required Intervention
• Patient Age: 00027 YR