MAUDE Adverse Event Report: NEURO - VILLALBA PISCES Z QUAD; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 389033

Device Problems High impedance (1291); Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 12/01/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 389033, lot# j0306905v, implanted: (b)(6) 2005, explanted: (b)(6) 2015.(b)(4).For information regarding the patient's implantable neurostimulator replacement please refer to manufacturer report # 3004209178-2015-23092.

Event Description

A manufacturer representative reported that the patient stopped receiving therapy about a week prior to (b)(6) 2015.The implantable neurostimulator (ins) was replaced.During the replacement the impedances were checked at 1.5v and combination 0-1 showed 1537 ohms but all other combinations with 0 as the reference electrode were over 4,000 ohms.The impedances were rechecked at 4v with 0-2, 0-3, and 0-5 all over 4,000 ohms.Combination 1-2 showed 1,074 ohms and the rest of the combinations with electrode 1 were over 4,000 ohms.Combination 4-5 showed 2,074 ohms and the rest of the combinations with electrode 4 were over 4,000 ohms.Combination 5-6 was 818 ohms, 5-7 was 2,074 ohms, and 6-7 was 1,378 ohms.They were using electrodes 1-2 and 4-5 for programming.There were no falls or trauma associated with the impedance issues.It was reviewed that impedances could be unreliable due to a low ins battery capacity as the battery was 10 years old.The patient's programming was electrode 1 negative, electrode 2 positive, 7.1v, with a pulse width of 450 microseconds, and a frequency of 40 hz.The patient also had electrode 4 positive, electrode 5 negative, 8.2v, 450 microseconds pulse width, and a frequency of 40 hz.Testing at 2v all of the impedances were greater than 4,000 ohms except combinations 0-1, 1-2, 2-3, 4-5, and 5-7 which were all 2,774 ohms.Combinations 5-6 and 6-7 were both at 1,842 ohms.Combinations 0-6, 1-6, 2-6, and 3-6 were all "?" values.Program 1's therapy impedance was 2,638 ohms and program 2's therapy impedance was 2,612 ohms.They were planning to move the patient's ins pocket up a little into the flank area.This was due specifically to a doctor decision and not due to a complaint.The ins and extensions were replaced during the revision.The impedances were still high after surgery.The patient was getting some stimulation but this changed based on movement.The patient was going to meet with their doctor to discuss a possible surgery to replace the leads.The patient was indicated for multiple back operations.No interventions or outcome were reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

• Brand Name: PISCES Z QUAD
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; villalba PR 00766
• 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: 5364415
• MDR Text Key: 35817643
• Report Number: 6000153-2016-00099
• Device Sequence Number: 1
• Product Code: LGW
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2010
• Device Model Number: 389033
• Device Catalogue Number: 389033
• Device Lot Number: V004688
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2015
• Date Device Manufactured: 03/14/2006
• 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: 00054 YR