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

Model Number 37602

Device Problem Low impedance (2285)

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

Event Type  Injury  

Event Description

It was reported that there was a short circuit which would be troubleshot intra-operatively on the date of this report during the battery change out.Pre-operative impedances for 2 and 3 were 30 ohms.C/2-678 ohms, c/3-672 ohms, c/1-860 ohms and it was unknown what c/0 was.The short had been reported 1.5 years prior to the date of this report but had not been addressed until recently about 1 month prior to the date of this report when the patient had been seen by a different healthcare professional.No patient outcome was provided regarding the event.Further follow-up is being conducted to obtain this information.If additional information is received a follow-up report will be submitted.

Manufacturer Narrative

Concomitant products: product id 3387s-40, lot # v327567, implanted: (b)(6) 2010, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 37642, serial # (b)(4), product type programmer, patient.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received reported that the cause of the impedance issue was found at the lead.The 2 and 3 contacts were fractured and the impedance did not resolve.The implantable neurostimulator (ins) was replaced with a rechargeable one.The doctor intended to use 2 and 3 for therapy, but the rechargeable ins would prevent it from draining at a rapid rate.

• 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: 4102736
• MDR Text Key: 4696248
• Report Number: 3004209178-2014-17398
• 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,Followup
• Report Date: 03/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2013
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2014
• Date Device Manufactured: 04/23/2012
• 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