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

Model Number 37601

Device Problem Low impedance (2285)

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

Event Date 11/26/2014

Event Type  Injury  

Event Description

Additional information received reported that the exploratory surgery was scheduled for (b)(6) 2014.

Event Description

It was reported that prior to removing the patient¿s implantable neurostimulator (ins) due to normal battery depletion, impedances were checked and all values were less than 1,000 ohms.After the ins was replaced, all impedances on the left except for c0 showed open.The right lead did not have any issues.To troubleshoot the healthcare professional (hcp) dried the leads off and then replaced them.The hcp then placed the right lead into the other port and they continued to see the open impedance values.During the patient¿s prior ins replacement, there were opens on the left lead that resolved after surgery when the patient was ambulatory.Since this happened before, the hcp decided to close the patient to see if the impedances resolved post operation.Post operation, the manufacturing representative performed a lead connection check and they saw ¿3 okay¿ on the screen.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.

Manufacturer Narrative

Concomitant medical products: product id: 3387s-40, lot# v265025, implanted: (b)(6) 2009, product type: lead.Product id: 37085-40, serial# (b)(4), implanted: (b)(6) 2009, product type: extension.Product id: 37601, serial# unknown, product type: implantable neurostimulator.(b)(4).

Event Description

Additional information received reported that exploration of the extension, lead, and implantable neurostimulator (ins) found the lead was electrically sound and the extension on the left side had multiple open circuits that did not resolve when tested on the right and left sides of the ins.A new extension was used and the open circuits were resolved.The existing ins and lead were left implanted.

Event Description

Additional information received reported that all impedances were greater than 40,000 ohms except for case and zero which were 791 ohms.The impedances had not resolved since implant.An x-ray was done and there were no obvious mechanical issues found.No fractures were noted on the x-ray.Multiple attempts were made to ensure that it was not an implantable neurostimulator (ins) and extension interface issue, but there was no success.The patient was waiting to be scheduled for an exploration of the lead/extension connection and lead impedance test.

• 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: 4334674
• MDR Text Key: 5435154
• Report Number: 3004209178-2014-24077
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2014
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2015
• Initial Date FDA Received: 12/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 12/31/2014; 01/06/2015; 01/13/2015
• Date Device Manufactured: 11/20/2012
• 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): Required Intervention
• Patient Age: 00064 YR