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 Intracranial Hemorrhage (1891); Dysphasia (2195)

Event Date 08/08/2013

Event Type  Injury  

Event Description

It was reported, the patient had a brain bleed the day after their left implant was put in.It was stated, the patient was not finishing their sentences.It was noted, it had ¿turned out to be worse¿ so the patient stopped talking and the brain bleed healed on its own.It was noted, the patient would go in for the right side deep brain stimulation (dbs) implant soon.It was noted, the patient was going to have an mri performed and it was related to the implantable neurostimulator (ins).It was noted, the mri would be performed before the right side ins was put in.It was further reported, the patient had a rough couple of weeks following the unilateral surgery.It was noted since then the patient had recovered and they were doing well.

Manufacturer Narrative

Product id 3387s-40, lot# va08kln, implanted: 2013 (b)(6); product type lead product id 748351, serial# (b)(4), implanted: 2013 (b)(6); 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: 3630711
• MDR Text Key: 3990546
• Report Number: 3004209178-2014-03113
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2014
• Date Device Manufactured: 04/22/2013
• 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): Other
• Patient Age: 00063 YR