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

Model Number 37612

Device Problems Therapy Delivered to Incorrect Body Area (1508); Charging Problem (2892)

Patient Problem Undesired Nerve Stimulation (1980)

Event Type  malfunction  

Event Description

It was reported that sometimes when the dystonia patient recharged their implantable neurostimulator (ins) he ¿felt a sense of power over the course of the extensions to the electrode.¿ it was noted the patient¿s system was intact and that impedance testing showed ¿normal impedances.¿ further troubleshooting was to be performed to check the patient¿s recharger.The patient ¿felt well¿ and was receiving ¿effective therapy¿ as of eight days after initial report.Later review of the patient¿s device and recharger data did not find any indication of a device issue.Additional information was requested; a supplemental report will be filed if additional information is received.

Manufacturer Narrative

(b)(4).

• 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: 4799338
• MDR Text Key: 5832274
• Report Number: 3004209178-2015-09752
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

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: 04/14/2010
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/27/2015
• Date Device Manufactured: 05/20/2009
• 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