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

Model Number 7428

Device Problem Failure to Deliver Energy (1211)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 08/23/2014

Event Type  malfunction  

Event Description

It was reported the parkinson¿s disease patient¿s ¿whole body became rigid¿ the day prior to report.The patient had visited their physician in (b)(6) 2014 and was told they had 18% of the battery remaining and that ¿it could last about six months.¿ however, when the patient used their programmer to check their battery the day prior to report, they ¿found the power indicator didn¿t light.¿ the patient was looking to have their implantable neurostimulator (ins) replaced as soon as possible at the time of report.Additional information was requested, but was unavailable at the time of report.A supplemental report will be filed if additional information is received.

Manufacturer Narrative

(b)(4).

• Brand Name: KINETRA
• 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: 4101402
• MDR Text Key: 18292982
• Report Number: 3004209178-2014-17351
• Device Sequence Number: 1
• Product Code: MHY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2011
• Device Model Number: 7428
• Device Catalogue Number: 7428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2014
• Initial Date FDA Received: 09/19/2014
• Date Device Manufactured: 06/18/2010
• 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: 00067 YR