MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems High impedance (1291); Pocket Stimulation (1463)

Patient Problems Undesired Nerve Stimulation (1980); Burning Sensation (2146); Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported there was high impedance of >40,000 on contact 10 ¿ c <(>&<)>10/8<(>&<)>10/9<(>&<)>10/10<(>&<)>11.The patient had a shocking/jolting sensation around the pocket.A revision was required as a result of the event and they changed out the extension.The patient had a burning sensation at the device pocket and their status at the time of report was alive with no injury.The product issue was resolved after the new extension was implanted and ¿everything was good.¿ no patient death was noted.

Manufacturer Narrative

Concomitant medical products: product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: extension.Product id: 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension.Product id: 3387s-40, lot# va0jfw2, implanted: (b)(6) 2014, product type: lead.Product id: 3387s-40, lot# va0jq82, implanted: (b)(6) 2014, product type: lead.Product id: neu_unknown_prog, serial# unknown, product type: programmer, physician.(b)(4).

Manufacturer Narrative

Analysis of the extension (b)(4) found the conductor of the extension body was broken within 10 cm of the connector area.The #2 conductor was broken 2.9 cm from the proximal end.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Supplemental submitted to update conclusion code.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; 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: 4336589
• MDR Text Key: 5140905
• Report Number: 3004209178-2014-24113
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2014
• 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