MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

Model Number 37612

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Delayed Charge Time (2586)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The healthcare provider (hcp) reported the dystonia patient's implantable neurostimulator (ins) had turned off and the patient experienced a "return of symptoms." it was also reported the patient had experienced an "increased recharging time" with the ins.While the cause of the event was unknown, the hcp noted the patient "claimed that the ins was not discharged." the patient turned the ins back on following the incident; however the recharging time remained increased at that time.Interrogation of the ins at the time of report found an out-of-range impedance of 2208 ohms on unipolar electrode 0.The issue was not resolved.There was no surgical intervention planned or undertaken.Additional information was requested; a supplemental report will be filed if additional information is received.

• Brand Name: ACTIVA
• Type of Device: IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
• 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: 5110293
• MDR Text Key: 27177775
• Report Number: 3004209178-2015-18872
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Report Date: 09/02/2015

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: 05/28/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Date Device Manufactured: 07/09/2010
• 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