MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37602

Device Problems Premature Discharge of Battery (1057); No Device Output (1435); Low impedance (2285); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Impedance Problem (2950)

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

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional via a manufacturing representative reported a patient whose indication for use is dystonia with bilateral globus pallidus intermediate (gpi) deep brain stimulators presented on (b)(6) 2016 with the right battery reading at end of service (eos) just 2 months after replacement.The battery voltage measurement read 2.94 but also showed eos and the battery could not be turned on.The generator appeared to be off but therapy impedance showed a high current reading.The patient did not report worsening of left sided dystonia.Some impedance were low but none were lower than 369.Therapy impedance was 93 which potentially indicated a short circuit.When the battery was interrogated a message was seen stating the delivered amplitude may be lower than the selected amplitude for one or more programs.The right device b setting was 0-2+, 5.0v, 90 usec, and 185 hz and a setting was 0-2+, 3.8v, 100 usec and 185 hz.Impedance values were c/0-369, c/1-642, c/2-808, c/3-731, 0/1-571, 0/2-556, 0/3-777, 1/2-914, 1/3-1010, 2/3-1022.X-rays from (b)(6) 2016 were reviewed and no evidence of lead fracture was found, however both of the lead connectors were overlying the mastoid making them more susceptible to fracture.There was likely a short circuit somewhere due to eos after 2 months and therapy impedance reading low, so they discussed typical plan for replacement of implantable neurostimulator and extension and potential for another surgery to replace the lead if that did not work.

Manufacturer Narrative

Information references the main component of the system, other applicable components are: product id: 3389s-40, lot# v167785, implanted: (b)(6) 2008, product type: lead.Product id: 3389s-40, lot# v158028, implanted: (b)(6) 2008, product type: lead.

Event Description

Additional information was received from a manufacturer representative (rep).It was reported that the patient was scheduled for a right lead replacement on (b)(6).No other information was received.

Event Description

Additional information received from a manufacturing representative reported the implantable neurostimulator (ins) reached end of service (eos) and there was an allegation/dissatisfaction with the ins longevity.The ins was programmed to 0-, 2+ at 5v, 185 usec, and 90 hz.No shorts were noted, but impedances electrode pairings with electrode zero were lower.The patient's health care provider (hcp) planned to test the impedances of the lead first.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5654532
• MDR Text Key: 45193001
• Report Number: 3004209178-2016-09487
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Date Device Manufactured: 10/17/2015
• 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