MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37603

Device Problems High impedance (1291); Device Operates Differently Than Expected (2913)

Patient Problem Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3387s-40, lot# va10bnh, implanted: (b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0z59j, implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

Information was received from a health care professional (hcp) regarding a patient who was implanted with an implantable neurostimulator (ins) for dystonia and movement disorders.It was reported impedance measurements were taken and c/0 was 1,190 ohms but all of the other values were at >40,000 ohms.They took x-rays and everything looked normal.The patient would go for a revision which was not scheduled yet.The patient was getting good therapy to the other side and so "they knew she responded well to therapy".The patient "retched" for approximately 10 hours at the time the stimulation was turned on.It was a sudden change.The issues occurred 3 weeks after implant when the stimulation was turned on.Further follow-up was being conducted to determine what actions/interventions were taken and what the cause of the retching and high impedances were.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 5442074
• MDR Text Key: 38376275
• Report Number: 3004209178-2016-02976
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/26/2016
• Date Device Manufactured: 10/17/2015
• 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): Required Intervention
• Patient Age: 00039 YR