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

Model Number 37603

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

Patient Problems Death (1802); Fall (1848); Muscle Weakness (1967); Neurological Deficit/Dysfunction (1982); Seizures (2063); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported the patient had a total of 3 surgeries for the deep brain stimulator (dbs) system.They had done well with the first two surgeries but the third surgery ¿totally did him in.¿ he had lost muscle strength, had seizures, big falls, and towards the end of his life when he was in the hospital he could not control moving his right foot.The patient was told they had parkinson¿s disease but originally the patient was not diagnosed with that and he just had essential tremors pre-dbs surgeries.No further follow-up is being done on this event as the patient died and it was stated to be unrelated to the device or therapy.The death occurred following the event and therefore, unable to follow-up for patient outcome.Please see manufacturer report #3004209178-2015-04324 for information on the patient's concomitant system.

Manufacturer Narrative

Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator; product id 3387s-40, lot# v556377, implanted: (b)(6) 2011, product type: lead; product id 37642, serial# (b)(4), product type: programmer, patient; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension; product id 3387s-40, lot# v603771, implanted: (b)(6) 2011, product type: lead; product id 37085-40, serial# (b)(4), implanted: (b)(6) 2011, 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: 4577570
• MDR Text Key: 21931180
• Report Number: 3004209178-2015-04326
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2015
• Date Device Manufactured: 02/10/2011
• 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
• Patient Age: 00085 YR