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

Model Number 37612

Device Problems High impedance (1291); Connection Problem (2900)

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

Event Date 04/14/2014

Event Type  malfunction  

Event Description

It was reported that the patient¿s implantable neurostimulators (ins) were being replaced with two rechargeable ins¿s due to the requirements for her high settings; she was running around 6 volts.The impedances were fine preoperatively, but after replacement at 3 volts all of the impedances were greater than 40,000 ohms with the exception of combination case and zero.The doctor was having issues inserting the extension with both ins¿s.The doctor reinserted the extensions into the old ins¿s without issues.The doctor felt much more resistance with the new ins¿s insertion and getting the extension seated may have been the issue.Later that day it was reported that the doctor had difficulty inserting the lead into the extension.All connections on the right ins had high, out of range impedances.The reporter stated that she saw ¿funky¿ impedances intra-operatively.The reporter stated that some of these bad impedances were known and pre-dated the ins replacement.The reporter also stated that every time the extension was inserted into the ins, the doctor felt a lot of resistance and could not seat it all the way.The doctor tried seven times on the first side and still had one open circuit.The doctor ended up using the bottom port because the top port was all greater than 40,000 ohms.The doctor recommended that the extension had a marker on it to ensure that the extension was properly inserted.Further in the day it was reported that the left ins had impedances greater than 40,000 ohms with electrode 11.The right ins had impedances between 10,000 and 20,000 ohms on all electrodes.The doctor noted that impedances and insertion were both fine when going back to the old ins¿s.The doctor encountered the same issues after trying the new ins¿s again.At the time of the report the patient was alive with no injury.

Manufacturer Narrative

Concomitant medical products: product id: 37612, serial# (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator.Product id: 3391s-40, lot# v597842, implanted: (b)(6)2012, product type: lead.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.Product id: 3391s-40, lot# v597842, implanted: (b)(6) 2012, product type: lead.Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2012, product type: extension.(b)(4).

Event Description

Upon additional review, it was determined that there was no difficulty reported regarding inserting the lead into the extension.

Event Description

Additional information received reported the connector block with no extension/lead in reflected >40,000 on all.There was an open on electrode 11 on the left lead.It was noted with the right impedances, it was suspected that the extension may have pulled completely free from the ins.If that was the case, then the impedances in the 12k to 23k range on all electrodes were due to fluid having filled the ins connector bore.

Event Description

It was further reported there were some impedance issues.The impedance measurements showed: left ins c/8 666 c/9 2996 c/10 18,742 c/11 >40,000 8/9 2545 8/10 18, 975 9/10 16905 9/11 >40.00 10/11 >40,000 rt ins c/0 18,459 c/1 12,667 c/2 17,802 c/3 14, 942 0/1 18,813 0/2 23,252 0/3 20.924 1/2 15,841 1/3 13,892 2/3 15, 841 it was stated the last right ins impedances were done post rechargeable battery implant and were normal at that time.All of the contacts on the right were high and a change from the implant.

• 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: 3793873
• MDR Text Key: 4386036
• Report Number: 3004209178-2014-08596
• Device Sequence Number: 1
• Product Code: MFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• 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,Followup
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2014
• Date Device Manufactured: 05/16/2013
• 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 Age: 00034 YR