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

Model Number 37602

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Numbness (2415)

Event Date 04/30/2014

Event Type  Injury  

Event Description

It was reported that the patient had a feeling of numbness and pain.There was a disturbance in lifting the right upper limb developed due to numbness and pain in an area from the right implantable neurostimulator (ins) site to the lead in the right cervical area.On (b)(6) 2014, the stimulator and the extensions were replaced and relocated, and subsequently the symptoms improved.The outcome was reported as recovered.Under the reason why it was serious it was noted ¿disability, led into a permanent dysfunction that hindered daily life.It was unknown if there was a 50 percent or greater symptom reduction.It was unknown what the cause of the event was.It was unknown if reprogramming or troubleshooting were required.It was unknown how the patient was doing or if they were receiving effective therapy.

Event Description

Additional information reported the stimulators were replaced.Neither left nor right side leads were replaced.Hospitalization was required due to the event.The adverse event was changed to disabled right upper limb.

Manufacturer Narrative

Concomitant products: product id 37602, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator; product id 3387-28, lot # unknown, implanted: (b)(6) 2014, product type lead; product id 3387-28, lot # unknown, implanted: (b)(6) 2014, product type lead; product id 7482-51, lot # unknown, implanted: (b)(6) 2014, product type extension; product id 7482-66, lot # unknown, implanted: (b)(6) 2014, product type extension.(b)(4).

• 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: 4558903
• MDR Text Key: 5561246
• Report Number: 3004209178-2015-03899
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2015
• Date Device Manufactured: 07/12/2013
• 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): Hospitalization; Required Intervention; Disability
• Patient Age: 00049 YR