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

Model Number 37603

Device Problems High impedance (1291); Electro-Static Discharge (2149); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported the patient observed an ¿oor¿ (out of regulation) error code on their patient programmer.The patient had reportedly experienced the issue when trying to adjust his settings in therapy group b by increasing his voltage to 4.2 volts.It was noted the patient ¿claimed that this occurred after really bad weather with heavy thunder and lightning.¿ impedance testing found that unipolar electrode 0 had a ¿high¿ impedance of 2525 ohms.Additionally, bipolar electrode impedances 0-1, 0-2, and 0-3 had high impedances of 2401 ohms, 2791 ohms, and 3069 ohms respectively.The patient was noted to have ¿gotten the best therapeutic effect on group a, but needed an alternative group because of tolerance to the settings when not changing.¿ there was no patient harm, injury, or death due to the event.Upon changing the patient¿s group b settings, it was noted the oor message was resolved and the patient was receiving effective therapy.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

Concomitant medical products: product id 37642, serial# (b)(4), product type: programmer, patient.(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: 4084623
• MDR Text Key: 18575948
• Report Number: 3004209178-2014-16903
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2014
• Date Device Manufactured: 08/09/2012
• 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