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

Model Number 37601

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Discomfort (2330); Neck Stiffness (2434)

Event Date 06/24/2013

Event Type  Injury  

Event Description

It was reported that the patient experienced redness at the left frontal incision without ¿drain.¿ corrective action included medication added, discontinued or dose change.The medication was bactrim.The event was reported as resolved.The patient also experienced neck discomfort due to pulling of the extension.Corrective action was noted as ¿other¿ and the event was not resolved.

Manufacturer Narrative

Concomitant products: product id: 3387, lot# unknown, product type: lead.Product id: 3387, lot# unknown, product type: lead.Product id: neu_unknown_ext, lot# serial# unknown, product type: extension.Product id: neu_unknown_ext, lot# serial# unknown, product type: extension.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va01k4q, product type: lead.Product id 3387s-40, lot# va 01k4q, product type: lead.Product id 3708660, serial# (b)(4), product type: extension.Product id 3708660, serial# (b)(4), product type: extension.The manufacturing site id was previously reported as #3007566237.Additional information indicates the correct manufacturing site id is 3004209178.

Event Description

Additional information reported the adverse events were related to the implant procedure and study.

Event Description

Additional information also indicated "swelln.".

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that corrective actions included continued neck exercises.

• 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 MN 55421 1200
• 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: 4657287
• MDR Text Key: 15226817
• Report Number: 3007566237-2015-00868
• 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: 09/09/2016

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: 09/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 04/03/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/07/2015; 05/11/2016; 07/06/2016; 09/09/2016
• Date Device Manufactured: 04/08/2013
• 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