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

Model Number 37602

Device Problems Premature Discharge of Battery (1057); High impedance (1291); Low impedance (2285); Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that the patient had a loss of therapeutic effect.He felt a therapy ¿fall off¿ in the month prior to the report and had not had any significant falls or trauma.When he was lying on his right side his therapy would change.The manufacturer representative (rep) stated that the impedances had been ¿high¿ since implant, but then later stated they had been fine in the past.It was unclear when the impedance issues began and the actual values provided appeared to be within the normal range.The implantable neurostimulator (ins) was at end of service (eos) and the voltage showed 2.83 volts.A longevity calculation was performed based on the patient¿s settings and noted that the battery should last five and a half years.Five days later the rep mentioned that the healthcare provider (hcp) was scheduling a replacement of the ins and extension.It was reported that a short circuit was discovered in the patient¿s system, which led to premature battery depletion.

Manufacturer Narrative

Concomitant medical products: product id: 7482a51, serial# (b)(4), implanted: 2007-(b)(6), product type: extension.Product id: 3387s-40, lot# v055961, implanted: 2007-(b)(6), product type: lead.(b)(4).

• 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: 4672397
• MDR Text Key: 5607041
• Report Number: 3004209178-2015-06230
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/19/2015

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: 03/28/2015
• 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: 03/19/2015
• Initial Date FDA Received: 04/09/2015
• Date Device Manufactured: 10/10/2013
• 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 Outcome(s): Required Intervention