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

Model Number 37601

Device Problems High impedance (1291); Low impedance (2285); Battery Problem (2885)

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

Event Type  Injury  

Event Description

It was reported the patient¿s implantable neurostimulator (ins) was replaced several months ago.The patient thought the ins was replaced too soon and they were told that there was ¿some kind of short in the lead wire.¿ high impedances were measured on contact one of the patient left brain.The patient further stated that during the replacement they went around the short.The patient¿s healthcare professional (hcp) told them the ins should last longer than a year with the ins in their chest.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 3389-40, lot# j0206490v, implanted: (b)(6) 2002, product type: lead.Product id: 3389-40, lot# j0206490v, implanted: (b)(6) 2002, product type: lead.Product id: 3389-40, lot# j0206490v, implanted: (b)(6) 2002, product type: lead.Product id: 3389-40, lot# j0206490v, implanted: (b)(6) 2002, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2002, product type: extension.Product id: neu_unknown_prog, serial# unknown, product type: programmer, physician.(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: 4243075
• MDR Text Key: 5012341
• Report Number: 3004209178-2014-21295
• 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: Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2013
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/20/2014
• Date Device Manufactured: 03/16/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 00075 YR