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

Model Number 37601

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209)

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

Event Date 02/22/2011

Event Type  malfunction  

Event Description

It was reported that the patient¿s implantable neurostimulator (ins) was turning on by itself.She turned it off at night and in the morning went to turn it back on, but it was already on and this showed on her programmer.She mentioned that the issue happened ¿every now and then¿ since implant.The patient followed the same routine every night and verified with her husband that it was off; there was no way she was accidentally hitting the white ins on button by mistake.The cause of the issue or intervention was not reported, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 3387s-40, lot# v526048, implanted: (b)(6) 2011, product type: lead.Product id: 3387s-40, lot# va0g15d, implanted: (b)(6) 2014, product type: lead.(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: 4622712
• MDR Text Key: 17936260
• Report Number: 3004209178-2015-05173
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2011
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2015
• Date Device Manufactured: 11/20/2009
• 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
• Patient Age: 00057 YR