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

Model Number 37602

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Impedance Problem (2950)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was reported that the patient had a loss of therapeutic effect.The healthcare provider (hcp) stated that ¿the patient had a loss of stimulation on the right lead.¿ the patient was having symptoms on the left side of his body and was hospitalized due to severe left hemisphere dystonia.The issue started ¿about ten days ago¿ and the patient had been hospitalized since (b)(6) 2014 due to the loss of stimulation.No falls or trauma had been reported.The implantable neurostimulator (ins) showed that it had been on 100% of the time and ¿settings were working fine,¿ but a high impedance was seen on unipolar 0.However, the patient was not programmed using 0.The hcp tried taking impedances when the patient was in different positions, but they were not catching it not working.The hcp did not suspect an ins problem, but more of a lead problem.The hcp noted the left side impedances were fine.The hcp stated that a ct scan was performed and the lead looked roughly in place, but it was hard to tell.The ct scan did not show anything broken, but imaging was difficult since the patient was moving a lot.Further imaging was planned.Later that day it was reported that the patient could not move around for the last four days.The reporter stated that the patient was young and growing, so wondered if ¿things had moved.¿ the reporter was going to meet with the patient and hcp and more imaging would be done.The reporter noted that the hcp could not replicate the high impedances on unipolar 0.The reporter stated that the patient may take days to react from the programming, so it was a difficult case.Further in the day it was reported that with the patient¿s head turned to the side there was no drastic change in the impedances.It was noted that the therapy change came very dramatically.The patient had not experienced any burning or shocking at any point.Two days later, it was reported that the hcp was planning to do a ct image the following day, but the reporter received no update.Additional information was requested, but was not available as of the date of this report.Refer to manufacturing report #3004209178-2014-09557 as the patient had a similar issue that resolved via lead replacement in 2011.

Manufacturer Narrative

Product id 37602, serial# (b)(4), implanted: 2012 (b)(6); product type implantable neurostimulator product id 37642, serial# (b)(4); product type programmer, patient product id 3387s-40, lot# v712879, implanted: 2011(b)(6); product type lead product id 7482a40, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 3387-40, lot# j0511466v, implanted: 2005 (b)(6); product type lead product id 748240, serial# (b)(4), implanted: 2005 (b)(6); product type extension (b)(4).

Manufacturer Narrative

Concomitant product(s): product id: 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3387s-40, lot# v712879, implanted: (b)(6) 2011, product type: lead.Product id: 7482a40, serial# (b)(4), implanted: (b)(6) 2011, product type: extension.Product id: 3387-40, lot# j0511466v, implanted: (b)(6) 2005, explanted: (b)(6) 2014, product type: lead.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2005- explanted: (b)(6) 2014, product type: extension.Product id: 3387-40, lot# j0511466v, implanted: (b)(6) 2005, explanted: (b)(6) 2014, product type: lead.Product id: 748240, serial# (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2014, product type: extension.(b)(4).

Event Description

It was later reported that the entire system on the right side had failed in the spring prior to the date of this report and had to be replaced in (b)(6) 2014.The lead was replaced on (b)(6) 2014 and the implantable neurostimulator (ins) and extension were replaced earlier in (b)(6) 2014.The left side was worse and that was why they had done the revision.It was noted that the patient had had a new system implanted on the right side and the lead was removed but some partial was infused into the patient's skull.The patient was doing better now and had been seen by the healthcare professional on monday prior to the date of this report.

Manufacturer Narrative

Concomitant medical products: product id 3387-40, lot# j0511466v, implanted: (b)(6) 2005, explanted: (b)(6) 2014, product type: lead.Product id 748240, serial# (b)(4), implanted: (b)(6) 2005-05-09, explanted: (b)(6) 2014, product type: extension.(b)(4).

Event Description

Additional information received reported that the cause of the event was the malfunction of the patient's right sided system.The event was attributed to the right lead and extension and there was an open circuit on contact 0 initially.Diagnostic imaging came back normal and multiple interrogations and reprogramming was not effective.The patient had a loss of therapy with severe dystonia worsening on the right side.The dystonia was reported to be life-threatening.Severe scarring over the extension and lead was found at surgery.The lead and extension were revised and replaced.The extension was replaced on (b)(6) 2014 and the lead on (b)(6) 2014.The patient was hospitalized for 38 days and the patient outcome was noted as a serious life threatening injury or illness where he was recovering without sequela.The patient's symptoms began to improve by the week of post-op.

• 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: 3830267
• MDR Text Key: 4449231
• Report Number: 3004209178-2014-09565
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2014
• Date Device Manufactured: 08/10/2012
• 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): Hospitalization; Life Threatening; Required Intervention