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

Model Number 37602

Device Problems Break (1069); High impedance (1291); Low impedance (2285); Device Contamination with Chemical or Other Material (2944)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

It was reported that there were impedance readings of greater than 2000 ohms.There was a loss of therapeutic effect.It was noted that they were calling from the operating room.The patient had been taken in for a revision due to the loss of therapy.It was noted that there was no good medical history at the time of this report.Impedances were c/0-6473, c/1-6776, c/2-7193, c/3-7874, 1/3 and 0/3 were high and there was nothing less than 250.Therapy impedance and settings were not available.The patient was programmed at c+1-.They were going to start at the lead/extension with the twistlock connector and they were looking for connector block alignment, fluid or anything that was frayed.It was further noted that the loss of therapy had been sudden about a week or two prior to the date of this report.Impedances had been done directly on the lead at 1.5v and all were greater than 2000 and at 3v all were in range.There was a kink seen in the lead when they had disconnected.The lead was being replaced.Additional information received reported that the lead was determined to have a short.It was kinked in part of the coil and now fluid was in the lead.The lead was replaced.It was reconnected to the system and all measurements were within speculations.The lead had been damaged during explant by the healthcare professional.

Manufacturer Narrative

Concomitant products: product id neu_unknown_ext, serial # unknown, implanted: (b)(6) 2012, product type extension; product id 3389s-40, lot # v838904, implanted: (b)(6) 2011, product type lead; product id 7482a66, serial # (b)(4), implanted: (b)(6) 2012, product type extension; product id 3389s-40, lot # v838904, implanted: (b)(6) 2012, product type lead; product id 37602, serial # (b)(4), implanted: (b)(6) 2012, product type implantable neurostimulator.(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: 3937678
• MDR Text Key: 4578139
• Report Number: 3004209178-2014-13064
• 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
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2012
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2014
• Date Device Manufactured: 06/13/2011
• 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
• Patient Age: 00061 YR