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

Model Number 37603

Device Problems Low impedance (2285); Low Battery (2584)

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

Event Type  Injury  

Event Description

It was reported there was battery depletion.It was stated there was low impedances of 49 ohms on electrodes 2 and 3.It was stated a replacement surgery was required as a result.It was noted the issue was not resolved.It was noted they may have tried to program around the short.It was noted the patient¿s device was at end of service (eos).It was stated the patient¿s status at the time of report was alive with no injury.It was noted no patient symptoms occurred.It was noted the device was at eos and impedances showed a short circuit on contacts that were utilized on 3 and 2.It was noted the device was replaced.It was further reported the date the eos was seen was on (b)(6) 2014.It was noted the patient did not know when the message began.It was stated the patient had used contact 3 and 2 with 5.2v for therapy control.It was noted the patient received therapy after the generator change.

Manufacturer Narrative

Product id: 3387s-40, lot# va02kce, implanted: (b)(6) 2013, product type: lead.Product id: 3387s-40, lot# va02kce, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension.Product id: 3389s-40, lot# va01er8, implanted: (b)(6) 2012, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer.Patient product id: 37603, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 37092, lot# 359340001, implanted: (b)(6) 2013, product type: accessory.Product id: 37642, serial# (b)(4), product type: programmer.(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: 3821427
• MDR Text Key: 4500047
• Report Number: 3004209178-2014-09281
• 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: 04/28/2014

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: 01/14/2014
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2014
• Initial Date FDA Received: 05/20/2014
• Date Device Manufactured: 07/16/2012
• 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
• Patient Age: 00040 YR