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

Model Number 7428

Device Problems Low impedance (2285); Device Contamination with Chemical or Other Material (2944)

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

Event Type  Injury  

Event Description

It was reported that during pre-operation a short was found.The implantable neurostimulator (ins) was being replaced due to normal battery depletion.When the patient¿s ins pocket was opened up to change out the ins, the healthcare professional (hcp) discovered that a breast implant had ruptured and there was silicon in the pocket on the deep brain stimulation components.The hcp clean up the silicone, implanted the new ins, and impedances were fine.The hcp suggested the implant puncture was not related to the device, but was due to age.The patient¿s ins pocket was on their right shoulder.Prior to the replacement surgery the patient mentioned having a couple of falls.There were no concerns about the ins battery longevity.

Manufacturer Narrative

Product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension.(b)(4).

• Brand Name: KINETRA
• 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: 4295195
• MDR Text Key: 5193890
• Report Number: 3004209178-2014-22518
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2012
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2014
• Date Device Manufactured: 02/02/2011
• 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): Required Intervention
• Patient Age: 00067 YR