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

Model Number 37602

Device Problems Unintended Collision (1429); Low impedance (2285); Battery Problem (2885)

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

Event Type  malfunction  

Event Description

It was reported that one of the patient¿s falls that had occurred about a year prior to the date of this report had most likely caused a short in the lead in the patient¿s brain.The healthcare professional did not think that the patient was a good candidate for surgery as the patient took plavax which was a blood thinner.The patient took this due to a heart attack that the patient had had 2 years prior to the date of this report.The patient had already had a battery replacement once but it had only lasted 3 months and the rechargeable system was recommended to the patient.Reference manufacturer¿s report number: 3004209178-2014-00651.

Manufacturer Narrative

Concomitant products: product id 37602, serial # (b)(6), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type implantable neurostimulator; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3387s-40, lot # v499735, implanted: (b)(6) 2010, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3387s-40, lot # v020086, implanted: (b)(6) 2007, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2007, product type extension; product id 37602, serial # (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type implantable neurostimulator.(b)(4).

Manufacturer Narrative

Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: implantable neurostimulator.Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2010, product type: extension.Product id 3387s-40, lot# v499735, implanted: (b)(6) 2010, product type: lead.Product id 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id 3387s-40, lot# v020086, implanted: (b)(6) 2007, product type: lead.Product id 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension.Product id 37602, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2013, product type: implantable neurostimulator.

Event Description

When the left battery was replaced with a new one, there were still low impedances at all bipolar configurations indicating it was a problem with the "electrode." it was stated that "when the current was run up from 0.70 to 1.50, only the 1 and 2 configuration corrected (normal impedance)." patient's settings were reprogrammed and the battery was turned back on.The settings remained at 4.6v, 2+, 1-, 90 microseconds, 135 hz, parameters with upper limit of 5.0 v and lower limit of 0.0 v, therapy impedance 125 ohms and 29.9 ma.The patient did not require hospitalization and the patient outcome was reported as no injury.Reference manufacturer's report number: 3004209178-2014-00651, the above information was previously reported under the referenced report number and additional review of the file indicated that the information provided above also pertained to the device documented under this report number.Additional information received reported the replacement on (b)(6) 2013 due to a short wire was caused by a patient fall.The patient was last seen in (b)(6) 2014.If additional information is received a supplemental report will be submitted.

• 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: 4050976
• MDR Text Key: 4861542
• Report Number: 3004209178-2014-16195
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2014
• Initial Date FDA Received: 09/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/13/2014
• Date Device Manufactured: 06/25/2013
• 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: 00066 YR