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

Model Number 37612

Device Problem Break (1069)

Patient Problems Distress (2329); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Additional information received reported that the broken leads were confirmed by x ray.It was also noted that the patient¿s last successful recharge was over a year ago and overdischarge was suspected.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 37612, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.Product id 3391s-40, lot# v597842, implanted: (b)(6) 2012, product type: lead.Product id 37651, serial# (b)(4), product type: recharger.Product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id 3391s-40, lot# v597842, implanted: (b)(6) 2012, product type: lead.Product id 37651, serial# (b)(4), product type: recharger.Product id 3391s-40, lot# v597842, implanted: (b)(6) 2012, product type: lead.Product id 3391s-40, lot# v597842, implanted: (b)(6) 2012, product type: lead.(b)(4).

Event Description

It was later reported that the patient's leads were broken.Reference manufacturer's report number: 3004209178-2015-07206.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from a health care provider (hcp) via a manufacturing representative reported the patient was disabled and had severe obsessive compulsive disorder (ocd).(b)(6) qualified the patient for deep brain stimulation (dbs), which was implanted in 2012.The patient's psychiatrist dropped (b)(6) in 2014 and since the dbs expertise is limited, monitoring stopped.The leads had broken and the dbs was not functioning.The patient's hoarding and ocd had worsened.The patient needed treatment to stabilize the ocd and then make a decision to remove or repair the dbs.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient via a manufacturer representative (rep) reported that the therapy for obsessive compulsive disorder (ocd) was not working or functioning.There was also no psychiatrist available in the area to monitor it.

Event Description

Additional information was received from a patient.It was reported that the patient has not had a functioning device in 2 years.A loss of stimulation and broken leads were noted.The patient is searching for a new health care provider (hcp) to manage his device as the surgeon will not redo the surgery until a managing hcp is found.The patient reported that her ocd hording has gotten worse and she ¿was upset that they got the card¿.

• 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: 4909174
• MDR Text Key: 16908624
• Report Number: 3004209178-2015-13224
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2016
• Date Device Manufactured: 05/16/2013
• 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