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

Model Number 37602

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

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

Event Type  Injury  

Event Description

Additional information received reported the patient was scheduled for the replacement of the lead, extension, and implantable neurostimulator (ins) on 2015-(b)(6).The patient had a short on one contact, but even with reprogramming around the contact, the ins was rapidly depleting.The manufacturing representative did not know when the depletion started.The ins had not reached end of service (eos), but the ins was low.The patient had been programmed in continuous mode.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the manufacturer representative (rep) believed that there was a short in the system that was contributing to the implantable neurostimulator (ins) depleting too quickly.The patient was in a procedure at the time of the report and wanted to use an alligator clip to test the extension.There was no confirmation if a short was found or what the patient outcome was, so additional information was requested.If additional information is received a supplemental report will be sent.

Manufacturer Narrative

Concomitant products: product id: 3387-40, lot# j0225368v, implanted: (b)(6) 2002, product type: lead.Product id: 7438, serial# (b)(4), product type: programmer, patient.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2002, : product type: extension.Product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 3389s-40, lot# va074ht, implanted: (b)(6) 2014, product type: lead.Product id: 748266, serial# (b)(4), implanted: (b)(6) 2002, product type: extension.(b)(4).

Event Description

Additional information received reported that the lead, extension, and implantable neurostimulator (ins) were all re-implanted on the right side.Everything was functioning normal at the time of the report.

Event Description

Additional information received from the patient via a manufacturer representative (rep) reported that there was an impedance failure on two of the leads on the right side implantable neurostimulator (ins) in (b)(6) 2014 with battery depletion.The plan was to do re-implantation of the right system on (b)(6)-2015; instead only an exploratory surgery was done and the right ins was removed.The post-op period was very challenging for the patient: there was an increase in medications, significant left leg tremors, and loss of function due to no ins.The patient had experienced component failure.The right system was completely replaced on (b)(6)-2015.The patient's outcome had been very good since with significant drug reduction and functional improvement.The patient's left side ins was replaced on (b)(6)-2015.Everything was working properly afterwards.

• 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: 4669659
• MDR Text Key: 17626200
• Report Number: 3004209178-2015-06199
• 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,company representative,con
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2015
• Date Device Manufactured: 11/30/2012
• 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