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

Model Number 37612

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330); Electric Shock (2554)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer reported via a manufacturer representative that the patient experienced an electrical sensation on the right side of their chest.The patient felt the sensation on and off, it was not very hard, and it lasted for approximately 10-20 seconds each time.The patient also felt discomfort right over the implantable neurostimulator (ins) connecting part.When the patient turned their neck, the ins jumped about 2.5 cm up and down.The ins was interrogated and impedances were measured to be within normal range.The ins was being regularly recharged and was a 100 percent charged.The ins was programmed to c+, 0-, 2-, 3- at 2.6v, 150 usec, and 130 hz on the left side and c+, 8-, 9- at 2.3v, 300 usec, and 130 hz on the right side.No further patient complications were anticipated/reported.The patient's indication for use is dystonia.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a health care provider (hcp) reported the patient had felt the sensations since the beginning of (b)(6) 2017.The patient did not experience any accidents or falls.The cause of the of the electrical sensations was not determined.Troubleshooting at the hcp's office included palpating over the extension and implantable neurostimulator (ins).No electrical sensations were provoked during the palpation.The ins was checked with the clinician programmer.The hcp was provided with additional information from the manufacturer representative and no actions have been taken or planned.The issue was not resolved.The patient was receiving effective therapy and they planned to contact the hcp if anything changes with the electrical sensations or their therapy.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6756550
• MDR Text Key: 81507219
• Report Number: 3004209178-2017-15960
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2011
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2017
• Date Device Manufactured: 06/18/2010
• 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