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

Model Number 37601

Device Problems Unintended Collision (1429); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Date 05/19/2015

Event Type  malfunction  

Event Description

It was reported that the patient had a change in therapy and therapy was intermittent/ erratic.It was also noted that the lead placement was not correct in 2008.The patient turned her therapy off at the beginning of (b)(6) 2015 and felt better with it off.The patient felt more alert and did not have tremor or anything.The patient followed up with dr (b)(6) the week of (b)(6) who confirmed that he was fine with the patient leaving the stimulator off.

Manufacturer Narrative

(b)(4).

Event Description

It was reported the patient had a loss of therapeutic effect following a fall two weeks prior to this report.When the patient fell, they fell on both of their knees.The patient had problems with their knees and their head hurt ¿so bad.¿ the patient¿s head hurt to turn over in their bed and they were not sure what settings their implantable neurostimulator (ins) was at.The patient believed something was not right with their programming because their head ¿hurts too much when they cough and the wires hurt their head.¿ 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 medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 6 4002, lot# n427056, implanted: (b)(6) 2014, product type: adapter.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 3387s-40, lot# v009531, implanted: (b)(6) 2008, product type: lead.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2008, product type: extension.Product id: 3387s-40, lot# v009531, implanted: (b)(6) 2008, 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: 4826847
• MDR Text Key: 6542253
• Report Number: 3004209178-2015-10502
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2015
• 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: 07/13/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/13/2015
• Date Device Manufactured: 12/03/2013
• 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 Age: 00068 YR