MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION PISCES-QUAD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 34872836

Device Problems High impedance (1291); Unable to Obtain Readings (1516)

Patient Problem Pain (1994)

Event Date 03/30/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 37703, serial# (b)(4), product type: implantable neurostimulator.(b)(4).

Event Description

The healthcare professional (hcp) of a foreign clinical study reported that the device diagnosis was high impedance.The clinical diagnosis was pain increased on the right leg.The outcome was ongoing.Interventions included reprogramming and a revision of the implantable neurostimulator (ins).Interventions included therapy suspended.The event resulted in an unscheduled clinic or office visit.The patient reported no change in the pain after new programming.The device was interrogated and device data did not show good information on the impedance because some of them indicated only by a point of interrogation (?).The etiology was noted as related to the device or therapy and not related to an implant procedure.The etiology was noted as the lead connected to the implantable neurostimulator (ins).The patient reported since a few days he felt more pain on his right leg.They tried to change programming but it was not enough because it was close to a change of the stimulator so it was decided to do a revision.During the intervention the impedances were tested and some were high.The stimulator was fine but they needed to change the lead.When the device was implanted the impedance was all correct and the stimulation worked well.

Event Description

Additional information received from the healthcare professional (hcp) of a clinical study reported that the outcome was resolved without sequelae.Interventions included reprogramming the device.Interventions included therapy suspended.Interventions included explanting and replacing the device.The lead was revised and there was a change of the stimulator.The event resulted in an unscheduled clinic or office visit.

• Brand Name: PISCES-QUAD
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5457685
• MDR Text Key: 38961240
• Report Number: 3007566237-2016-00995
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2003
• Device Model Number: 34872836
• Device Catalogue Number: 34872836
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2016
• 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