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

Model Number 3487A

Device Problems Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that a patient had stimulation in the wrong location during a post op visit following a (b)(6) procedure.It was stated that a lead revision to a paddle lead was planned but the date was unknown at this time.It was reported that impedance testing was performed and reprogramming were attempted but they were unable to obtain the desired coverage.The patient reported stimulation was only in his chest wall and upper back, rather than his neck and arm as it had been with is previous stimulation system.It was stated that an x-ray was ordered and it was reported that the lead tip was at t2 rather than in the cervical spine as placed intraoperatively.It was stated that the patient would be taken back to surgery next week to replace the lead with a paddle lead.It was noted that the patient was alive with no injury and had less than 50% therapy relief.It was further reported that the patient reported shocking and stimulation in the chest only.It was stated that impedances were normal and that a lead replacement was scheduled for (b)(6) 2014 for a ¿lami paddle lead.¿.

Event Description

It was confirmed that the reason for the implantable neurostimulator (ins) replacement was prophylactic.When the lead was planned to be replaced; the patient stated that they cannot live without their stimulation and requested that the ins be replaced as well with the lead, before the ins goes out too.The patient has been receiving effective therapy since replacement.

Manufacturer Narrative

Device analysis for lead va0ak40 revealed no significant anomaly.The body conductor was crushed.Device analysis for the anchor revealed no significant anomaly.The silicone was cut.

Manufacturer Narrative

Concomitant medical products: product id 3708340, serial# (b)(4), implanted: (b)(6) 2014, product type: extension; product id 97712, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator; product id 97740, serial# (b)(4), product type: programmer, patient; product id 97754, serial# (b)(4), product type: recharger; product id 3550-39, lot# n372850, implanted: (b)(6) 2014, product type: accessory; product id 74002, lot# n205624, implanted: (b)(6) 2011, product type: adapter; product id 37711, serial# (b)(4), implanted: (b)(6) 2011, product type: implantable neurostimulator; product id 399930, lot# j0555196v, implanted: (b)(6) 2005, product type: lead; product id 748925, serial# (b)(4), implanted: (b)(6) 2005, product type: extension; product id 748925, serial# (b)(4), implanted: (b)(6) 2005, product type: extension.(b)(4).(b)(6).

Manufacturer Narrative

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

• Brand Name: PISCES-QUAD
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 4068392
• MDR Text Key: 4815677
• Report Number: 3007566237-2014-02503
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2017
• Device Model Number: 3487A
• Device Catalogue Number: 3487A
• Device Lot Number: VA0AK40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2013
• 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