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 Muscle Weakness (1967)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported the patient had experienced her hands trembling.The patient was reprogrammed on (b)(6) 2014 and reportedly her ¿symptoms got better after programming.¿ then, five days prior to report, the ¿patient fell down because her legs were weak.¿ the patient went to the hospital to be reprogrammed nine days after initial report as a result; however, the patient¿s physician ¿didn¿t do any parameter adjustments¿ at that time.The physician examined the patient and told the patient she ¿had brain stem and suggested to do programming after the brain stem was cured.¿ the patient was hospitalized the following day ¿for treatment of brain stem.¿ it was noted the patients legs ¿were still weak¿ at that time and that the physician ¿said the symptom was caused by brain stem.¿ it was ¿unknown¿ whether the patient was receiving 50% or greater symptom reduction at that time.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information stated the previously reported patient having "brain stem" referred to the patient having a "cerebral infarction.".

• 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: 4377420
• MDR Text Key: 5261653
• Report Number: 3004209178-2015-00014
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2015
• Date Device Manufactured: 11/12/2013
• 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; Other
• Patient Age: 00072 YR