MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Swelling (2091); Complaint, Ill-Defined (2331)

Event Date 06/09/2015

Event Type  Injury  

Manufacturer Narrative

Previously the event was noted as a malfunction.Supplemental has been sent to update to serious injury.

Manufacturer Narrative

Final analysis of one of the leads with lot v014246 revealed the outer insulation was breached 33 centimeters from the distal end.Analysis of the other lead with lot v014246 revealed no significant anomalies.The lead body was cut through and segmented.Final analysis of extension (b)(4) revealed no significant anomalies.

Event Description

It was reported there was protrusion of the right extension on the head near the ear due to lead explant.The right lead was explanted and detached from the extension left at the time of lead explant.Upon inspection in the emergency room inflammation and infection was noted for the extension.The type of infection was unknown.The event required a hospital emergency room visit which resulted in admission.A cat scan was performed and swelling over the extensions was noted.The entire system was explanted as an intervention.The event was recovered with sequelae.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v014246, implanted:(b)(6) 2007, product type: lead.Product id: 64002, lot# n318565, implanted: (b)(6) 2012, product type: adapter.Product id: 3387s-40, lot# v014246, implanted: (b)(6) 2007, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.Product id: 748251, serial# (b)(4), implanted:(b)(6) 2007, explanted: (b)(6) 2015, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2007, explanted:(b)(6) 2015, product type: extension.Product id: neu_burrholecap, product type: accessory.Product id: neu_burrholering, product type: accessory.Product id: 3550-29, product type: accessory.Product id: 3387s-40, lot# v014246, implanted: (b)(6) 2007, product type: lead.Product id: neu_stimloc_acc, product type: accessory.(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the healthcare professional of a clinical study reported there was an infection at the extension tract and wound dehiscence.Cat scan results revealed soft tissue swelling in the right frontoparietal scalp.The chem 7 revealed abnormal results for glucose, complete blood count/red blood count, hemoglobin, hematocrit, mean corpuscular volume, mean cell hemoglobin, and mean platelet volume.Fungal and acid fast bacilli culture was negative, aerobic culture showed light growth of staph aureus and light growth of staph epidermidis.Hepatic alkaline phosphatase was raised, calcium, magnesium, osmobility, phosphate pathogen recognition receptors was slightly lower, urinalysis ketones.The system was explanted and debridement was done.Vancomycin, cefepime, and cefazolin were administered.The event was still considered recovered with sequelae.If additional information is received a follow-up report will be sent.

Manufacturer Narrative

Conclusion code was updated for the lead (lot # v014246).It is noted fdc is still applicable to the extension ((b)(4)) and the lead (lot # v014246).

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received from a healthcare professional of a clinical study indicating diagnostics included tests performed included computerized axial tomography (cat) scan with results indicating soft tissue swelling right frontal panetal scale, x-ray with normal results for the skull and chest.Other diagnostic indicated mean platelet volume was 8.9, acorobic culture = light growth staph aveus, light growth staph epidermis.Interventions included permanent discontinuation of stimulation.Medical therapy also included cefazolin 2000 mg three times a day via a picc line.The picc line was removed on (b)(6) 2015.The outcome was resolved without sequelae.Additional information was received which updated protrusion of extension due to lead explanted to skin erosion and etiology to skin erosion lead/extension tract.Diagnsotic methods were updated from hepatic alkaline phosphatase was raised, calcium, magnesium, osmobility, phosphate pathogen recognition receptors was slightly lower, urinalysis ketones to no diagnostic tests performed, emergency room visit.

Event Description

Additional information received reported the lead, extension and neurostimulator were explanted on (b)(6) 2015.There was no change to diagnostic tests performed.

Manufacturer Narrative

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

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 4889156
• MDR Text Key: 14225268
• Report Number: 3004209178-2015-12725
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2011
• 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; Required Intervention
• Patient Age: 00063 YR