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

Model Number 37602

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problem Muscle Spasm(s) (1966)

Event Type  malfunction  

Event Description

It was reported that the patient was having spasms in her hands and arms on the night prior to the date of this report.The patient had used her medic alert necklace on the day prior to the date of this report.The necklace was taken off on the morning of the date of this report and the patient had not had spasms in her hands and arms.The patient was going to try and put the necklace back on to see what would happen.No outcome was provided regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received a supplemental report will be submitted.Reference manufacturer¿s report number: 3004209178-2014-18142.

Manufacturer Narrative

Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator; product id 3389-40, lot# j0340291v, implanted: (b)(6) 2003, product type: lead; product id 748295, serial# (b)(4), implanted: (b)(6) 2005, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3389-40, lot# j0337392v, implanted: (b)(6) 2003, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2003, product type: extension.(b)(4).F.

• 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: 4134805
• MDR Text Key: 4926206
• Report Number: 3004209178-2014-18143
• 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: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2014
• Initial Date FDA Received: 10/02/2014
• Date Device Manufactured: 06/26/2013
• 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 Age: 00062 YR