MAUDE Adverse Event Report: IPG MFG SWITZERLAND KINETRA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 7428

Device Problems Low impedance (2285); Battery Problem (2885)

Patient Problems Complaint, Ill-Defined (2331); Depression (2361); Cognitive Changes (2551)

Event Date 02/27/2014

Event Type  Injury  

Event Description

It was reported the patient had a short circuit which was causing battery depletion.It was also noted that the patient had been doing worse for three weeks prior to their visit.The patient had been having more symptoms then previously.The intervention involved replacing the stimulator.The event was considered resolved without sequelae and noted as related to the device and not related to the implant procedure.It was noted the event resulted in in-patient hospitalization.Additional information updated the patient as doing worse to the patient was having more obsessive compulsive symptoms and depressive symptoms.The etiology was noted as the stimulator.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that there was a short circuit which was causing battery depletion.It was noted that the patient had more obsessive compulsive disorder (ocd) symptoms and depressive symptoms (low mood).It was noted that the symptoms were increasing over three weeks before coming to the visit.

• Brand Name: KINETRA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• 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: 3843159
• MDR Text Key: 4408983
• Report Number: 9614453-2014-01056
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2014
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/09/2014
• Date Device Manufactured: 03/08/2013
• 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): Hospitalization; Required Intervention