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 Problem Seizures, Focal Motor (2064)

Event Date 10/01/2014

Event Type  Injury  

Event Description

It was reported that the patient experienced myoclonic jerks of arms and legs.Corrective actions included medication added, discontinued or dose changed.Depakote was started after lab work was reviewed on (b)(6) 2014.The event was not resolved.

Manufacturer Narrative

Concomitant medical products: product id 3387, lot# unknown, product type: lead; product id 3387, lot# unknown, product type: lead; product id neu_unknown_ext, serial# unknown, product type: extension; product id neu_unknown_ext, 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 04z6f, 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 it was unknown if the myoclonic jerks were related to the study and programming.The suspected cause was unknown.

Manufacturer Narrative

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.

• 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: 4662492
• MDR Text Key: 5610262
• Report Number: 3007566237-2015-00895
• 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
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Date Device Manufactured: 11/08/2012
• 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): Other
• Patient Age: 00059 YR