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 Bruise/Contusion (1754); Fall (1848); Bone Fracture(s) (1870); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient had been falling for the past 3 months prior to the date of this report.The patient had taken some pretty hard falls and had been falling about 2-3-5 times a week.The patient had been losing her balance.The patient wanted to know if everything was ok with therapy.The last time the patient was in the healthcare professionals office was in (b)(6) prior to the date of this report and nothing was wrong when checked.There was a patient injury.Following the patient¿s worst fall she had spent 6 weeks in rehab for a cracked pelvic bone.The patient had fell two days prior to the date of this report and hit her head in the bathroom and had gotten a black eye which looked awful.The patient had had more than that and had hit her shoulder.The patient had a speech therapist she was working with and thought she was better that way for speech.The patient had lost the controller since (b)(6) prior to the date of this report.The patient had an appointment with her healthcare professional scheduled in (b)(6).No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received a follow-up report will be sent.

Manufacturer Narrative

Concomitant products: product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2013, product type extension; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3389s-40, lot # v436025, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot # v411494, implanted: (b)(6) 2010, product type lead.(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: 4096758
• MDR Text Key: 16172999
• Report Number: 3004209178-2014-17208
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2014

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: 05/14/2014
• 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: 08/28/2014
• Initial Date FDA Received: 09/17/2014
• Date Device Manufactured: 11/20/2012
• 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: 00076 YR